Handheld electromechanical surgical system

ABSTRACT

A handheld electromechanical surgical device, capable of effectuating a surgical procedure, includes a handle assembly having a power source; at least one motor coupled to the power source; and a controller configured to control the motor. The surgical device includes an adapter assembly having an electrical assembly having a proximal end in communication with the controller of the handle assembly. The surgical device includes a reload configured to selectively connect to a distal end of the adapter assembly. The reload includes an annular array of staples; an annular staple pusher for ejecting the staples; and a data storage device selectively connectable to a distal end of the electrical assembly. The data storage device receives and stores performance data of the surgical device from the controller of the handle assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation-in-Part Application which claims thebenefit of and priority to U.S. patent application Ser. No. 15/972,641,filed on May 7, 2018, now U.S. Pat. No. 11,045,199, which claims thebenefit of and priority to each of U.S. Provisional Patent ApplicationSer. No. 62/517,276, filed Jun. 9, 2017, and U.S. Provisional PatentApplication Ser. No. 62/517,297, filed Jun. 9, 2017. The entiredisclosures of all of the foregoing applications are incorporated byreference herein.

BACKGROUND 1. Technical Field

The present disclosure relates to surgical devices. More specifically,the present disclosure relates to handheld electromechanical surgicalsystems for performing surgical procedures.

2. Background of Related Art

One type of surgical device is a circular clamping, cutting and staplingdevice. Such a device may be employed in a surgical procedure toreattach rectum portions that were previously transected, or similarprocedures. Conventional circular clamping, cutting and staplinginstruments include a pistol or linear grip-styled structure having anelongated shaft extending therefrom and a staple cartridge supported onthe distal end of the elongated shaft. In this instance, a physician mayinsert an anvil assembly of the circular stapling instrument into arectum of a patient and maneuver the anvil assembly up the colonic tractof the patient toward the transected rectum portions. The physician mayalso insert the remainder of the circular stapling instrument (includingthe cartridge assembly) through an incision and toward the transectedrectum portions. The anvil and cartridge assemblies are approximatedtoward one another and staples are ejected from the cartridge assemblytoward the anvil assembly to form the staples in tissue to affect anend-to-end anastomosis, and an annular knife is fired to core a portionof the clamped tissue portions. After the end-to-end anastomosis hasbeen affected, the circular stapling apparatus is removed from thesurgical site.

A number of surgical device manufacturers have developed product lineswith proprietary powered drive systems for operating and/or manipulatingthe surgical device. In many instances the surgical devices include apowered handle assembly, which is reusable, and a disposable staplecartridge assembly, end effector or the like that is selectivelyconnected to the powered handle assembly prior to use and thendisconnected from the staple cartridge assembly or end effectorfollowing use in order to be disposed of or in some instances sterilizedfor re-use.

The use of powered electro and endomechanical surgical staplers,including intelligent battery power, has grown tremendously over thepast few decades. Advanced technology and informatics within theseintelligent battery-powered stapling devices provide the ability togather clinical data and drive design improvements to ultimately improvepatient outcomes. Accordingly, a need exists for improved poweredelectro and endomechanical surgical staplers that are capable ofevaluating conditions that affect staple formation with the intention ofbuilding a more intelligent stapling algorithm.

SUMMARY

The present disclosure relates to handheld electromechanical surgicalsystems for performing surgical procedures.

According to an aspect of the present disclosure, a handheldelectromechanical surgical device capable of effectuating a surgicalprocedure is provided. The surgical device includes a handle assemblyhaving a power source; at least one motor coupled to the power source;and a controller configured to control the motor. The surgical deviceincludes an adapter assembly coupled to and extending from the handleassembly. The adapter assembly includes a force transmitting androtation converting assembly for receiving and communicating a rotationfrom the at least one motor of the handle assembly to axiallytranslating forces of a driven assembly thereof; and an electricalassembly having a proximal end in communication with the controller ofthe handle assembly, and a distal end. The surgical device includes areload configured to selectively connect to a distal portion of theadapter assembly. The reload includes an annular array of staples; anannular staple pusher for ejecting the staples; and a data storagedevice selectively connectable to the distal end of the electricalassembly of the adapter assembly. The data storage device receives andstores performance data of the surgical device from the controller ofthe handle assembly.

The the data storage device of the reload may include informationpre-stored thereon prior to any use thereof. The pre-stored informationmay include at least one of lot number, staple size, knife diameter,lumen size, fire count, manufacturing stroke offsets, excessive forceindex, shipping cap assembly presence, or demonstration modes.

The data storage device of the reload may be configured to haveperformance data written thereto and stored thereon during or followingany use thereof.

The data storage device of the reload may be configured to haveperformance data written thereto and stored thereon following asuccessful or unsuccessful firing of the surgical device.

The performance data written and stored to the data storage device ofthe reload may include clamping forces for the surgical procedure,stapling forces for the surgical procedure, cutting forces for thesurgical procedure, a maximum clamping force, a maximum stapling forceor a maximum cutting force.

The performance data may be written and stored to the controller of thehandle assembly.

During or following any use of the surgical device, performance datarelated to the use of the surgical device is written to and stored inthe data storage device of the reload.

Following a successful or unsuccessful firing of the surgical device,performance data related to the successful or unsuccessful firing may bewritten to and stored in the data storage device of the reload.

The performance data written and stored to the data storage device ofthe reload may include clamping forces for the surgical procedure,stapling forces for the surgical procedure, cutting forces for thesurgical procedure, a maximum clamping force, a maximum stapling forceor a maximum cutting force.

The data storage device of the reload may include information pre-storedthereon prior to any use thereof, the pre-stored information includes atleast one of lot number, staple size, knife diameter, lumen size, firecount, manufacturing stroke offsets, excessive force index, shipping capassembly presence, or demonstration modes.

The performance data may be written and stored to the controller of thehandle assembly.

According to another aspect of the disclosure, a surgical stapler reloadconfigured for selective connection to a surgical device capable ofeffectuating a surgical procedure, is provided. The surgical staplerreload includes an annular array of staples; an annular staple pusherfor ejecting the staples; and a data storage device selectivelyconnectable to an electrical assembly the surgical device, wherein thedata storage device receives and stores performance data from acontroller of the surgical device.

The data storage device of the reload may include information pre-storedthereon prior to any use thereof, the pre-stored information includes atleast one of lot number, staple size, knife diameter, lumen size, firecount, manufacturing stroke offsets, excessive force index, shipping capassembly presence, or demonstration modes.

The data storage device of the reload may be configured to haveperformance data written thereto and stored thereon during or followingany use thereof.

The data storage device of the reload may be configured to haveperformance data written thereto and stored thereon following asuccessful or unsuccessful firing of the surgical device.

The performance data written and stored to the data storage device ofthe reload may include clamping forces for the surgical procedure,stapling forces for the surgical procedure, cutting forces for thesurgical procedure, a maximum clamping force, a maximum stapling forceor a maximum cutting force.

According to yet another aspect of the present disclosure, a method ofgathering surgical procedure performance data for a surgical device, isprovided. The method includes performing a surgical procedure with asurgical device. The surgical device includes a handle assembly having apower source; at least one motor coupled to the power source; and acontroller configured to control the motor; and a reload configured toselectively connect to the handle assembly. The reload includes anannular array of staples; an annular staple pusher for ejecting thestaples; and a data storage device selectively connected to thecontroller of the handle assembly. The method includes transmitting theperformance data of the surgical device from the controller thereof tothe data storage device of the reload; and storing the performance dataof the surgical device in the data storage device of the reload.

The method may further include transmitting and storing the performancedata to the data storage device of the reload following a successful orunsuccessful firing of the surgical device.

The performance data written and stored to the data storage device ofthe reload may include clamping forces for the surgical procedure,stapling forces for the surgical procedure, cutting forces for thesurgical procedure, a maximum clamping force, a maximum stapling forceor a maximum cutting force.

The method may further include writing the performance data and storingthe performance data in the controller of the surgical device.

The method may further include disconnecting the reload from thesurgical device; and accessing the performance data stored in the datastorage device of the reload.

The storing of the performance data of the surgical device in the datastorage device of the reload may occur while the surgical device is inthe field of use; and the accessing of the performance data stored inthe data storage device of the reload may occur while the reload isoutside of the field of use.

According to a further aspect of the present disclosure, a method isprovided of operating a surgical device including a surgical staplerreload and an anvil assembly having a head assembly movable between anon-tilted orientation for cooperation with the surgical staple reloadto form a plurality of surgical staples and a tilted orientation. Themethod includes, following a complete firing of the surgical device, andfollowing a tilting of the head assembly of the anvil assembly from thenon-titled orientation to the tilted orientation, monitoring an axialdistance of the tilted head assembly relative to the reload.

The method may further include monitoring forces acting on the anvilassembly as the anvil assembly is translated towards the reload.

The method may further include stopping axial translation of the anvilassembly when the forces acting on the anvil assembly exceed apredetermined threshold.

The method may still further include monitoring forces acting on thetilted head assembly of the anvil assembly as the tilted head assemblyis translated towards the reload.

The method may further include stopping translation of the tilted headassembly toward the reload when the forces acting on the tilted headassembly exceed a predetermined threshold.

According to the method, an increase in the forces being monitoredduring axial translation of the anvil assembly may be indicative oftissue being captured between the tilted head assembly and the reload.

The method may further include activating an alert when the forcesacting on the anvil assembly exceed the predetermined threshold.

The monitoring may be performed by a controller of the surgical device.

According to the method, the reload may be circular and may include atissue contacting surface defining a reload plane that is orthogonal toan axis of translation of the anvil assembly; and the head assembly ofthe anvil assembly may be circular and may include a tissue contactingsurface defining an anvil head plane that is (1) parallel to the reloadplane when the head assembly is in the non-titled orientation; and (2)angled relative to the reload plane when the head assembly is in thetilted orientation. The method may include monitoring when an outerradial edge of the head assembly is in relative close proximity to thetissue contacting surface of the reload while the head assembly is inthe tilted orientation.

The method may further include monitoring an axial position of a trocarmember of the surgical device relative to the reload for determiningwhen the tilted head assembly of the anvil assembly is in relative closeproximity to the reload.

According to yet another aspect of the present disclosure, a method isprovided for operating a surgical device including a removable surgicalstapler reload. The method includes attaching a selected surgicalstapler reload to the surgical device; a controller of the surgicaldevice reading information stored on the selected surgical staplerreload; and setting a maximum cut stroke for a knife of the selectedsurgical stapler reload based on the information stored on the selectedsurgical stapler reload.

The method may further include the controller of the surgical devicemonitoring an axial position of the knife of the selected surgicalstapler reload relative to a housing of the selected surgical staplerreload.

The information stored on the selected surgical stapler reload mayinclude at least one of staple size, knife diameter, lumen size, minimumcut stroke length, or maximum cut stroke length for the selectedsurgical stapler reload.

The method may further include setting a minimum cut stroke for theknife of the selected surgical stapler reload based on the informationstored on the selected surgical stapler reload.

The controller of the surgical device may set the cut stroke for theselected surgical stapler reload.

The selected surgical stapler reload may be a first selected surgicalstapler reload, and the method may include replacing the first selectedsurgical stapler reload with a second selected surgical stapler reload;and setting a maximum cut stroke for a knife of the second selectedsurgical stapler reload based on the information stored on the secondselected surgical stapler reload.

The cut stroke for the knife of the first selected surgical staplerreload may be different than the cut stroke for the knife of the secondselected surgical stapler reload.

Each surgical stapler reload may be an annular surgical stapler reloadincluding an annular knife and an annular array of staple.

According to a further aspect of the present disclosure, a method isprovided of operating a surgical device including a handheldelectromechanical surgical device capable of operating a surgical reloadcapable of effectuating a surgical procedure, and a surgical adapterassembly for selectively electrically and mechanically interconnectingthe surgical device and the removable surgical reload. The methodincludes mechanically and electrically attaching the adapter assembly tothe surgical device; a main controller of the surgical device queryingan event log of an electronic temperature sensor of the adapterassembly; and when the query indicates that the adapter assembly hasundergone a sterilization cycle, the main controller of the surgicaldevice permitting operation of surgical device to effectuate operationof the surgical reload via the adapter assembly.

The method may further include logging, by the electronic temperaturesensor of the adapter assembly, a sterilizing cycle for the adapterassembly.

The method may further include logging, by the electronic temperaturesensor of the adapter assembly, a temperature of the sterilizing cycle.

The method may still further include logging, by the electronictemperature sensor of the adapter assembly, a maximum temperature of thesterilizing cycle.

The method may further include logging, by the electronic temperaturesensor of the adapter assembly, a duration of the sterilizing cycle.

The method may still further include rendering the adapter assemblydisabled when the maximum temperature of the sterilization cycle is notobtained or when a minimum duration of the sterilization cycle is notobtained.

The method may further include rendering the surgical device disabledwhen the maximum temperature of the sterilization cycle is not obtainedor when a minimum duration of the sterilization cycle is not obtained.

The method may still further include the main controller of the surgicaldevice rendering the adapter assembly disabled when the maximumtemperature of the sterilization cycle is not obtained or when a minimumduration of the sterilization cycle is not obtained.

The method may further include the main controller of the surgicaldevice querying a number of sterilization cycles registered by theelectronic temperature sensor.

The electronic temperature sensor may be a thermistor.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure are described herein withreference to the accompanying drawings, wherein:

FIG. 1 is a perspective view of a handheld surgical device and adapterassembly, in accordance with an embodiment of the present disclosure,illustrating a connection thereof with an end effector or reload;

FIG. 2 is a front perspective view of a handle assembly of the surgicaldevice of FIG. 1 ;

FIG. 3 is a front, perspective view, with parts separated, of the handleassembly of FIG. 2 ;

FIG. 4 is a rear, perspective view, with parts separated, of the handleassembly of FIG. 2 ;

FIG. 5 is a perspective view illustrating an insertion of the handleassembly into an outer shell housing assembly, in accordance with thepresent disclosure;

FIG. 6 is a perspective view illustrating the handle assembly insertedin a proximal half-section of the outer shell housing assembly, inaccordance with the present disclosure;

FIG. 7 is a side, elevational view of the outer shell housing, shown inan open condition;

FIG. 8 is a front, perspective view of the outer shell housing, shown inan open condition;

FIG. 9 is a front, perspective view of the outer shell housing, shown ina partially open condition, and with an insertion guide removedtherefrom;

FIG. 10 is a rear, perspective view of the insertion guide;

FIG. 11 is a front, perspective view of the insertion guide;

FIG. 12 is a front, perspective view of a power handle with an innerrear housing separated therefrom;

FIG. 13 is a rear, perspective view of the power handle with the innerrear housing removed therefrom;

FIG. 14 is a perspective view of a power handle core assembly of thepower handle;

FIG. 15 is a front, perspective view of a motor assembly and a controlassembly of the power handle core assembly of FIG. 14 ;

FIG. 16 is a rear, perspective view, with parts separated, of the motorassembly and the control assembly of FIG. 15 ;

FIG. 17 is a longitudinal, cross-sectional view of the handle assemblyof FIG. 2 ;

FIG. 18 is an enlarged view of the indicated area of detail of FIG. 17 ;

FIG. 19 is a cross-sectional view of the handle assembly as takenthrough 19-19 of FIG. 17 ;

FIG. 20 is a front, perspective view of the adapter assembly of FIG. 1 ;

FIG. 21 is a rear, perspective view of the adapter assembly of FIGS. 1and 20 ;

FIG. 22 is a perspective view illustrating a connection of the adapterassembly and the handle assembly;

FIG. 23 is a perspective view of the adapter assembly, illustrating areload secured to a distal end thereof;

FIG. 23A is an enlarged perspective view of the indicated area of detailof FIG. 23 , illustrating a head assembly of an anvil assembly in atilted condition;

FIG. 24 is a perspective view of the adapter assembly without the reloadsecured to the distal end thereof;

FIG. 25 is a perspective view of the adapter assembly, shown partiallyin phantom, illustrating a first force/rotation transmitting/convertingassembly thereof;

FIG. 26 is a perspective view of the first force/rotationtransmitting/converting assembly of FIG. 25 ;

FIG. 27 is a longitudinal, cross-sectional view of a first rotatableproximal drive shaft, a first rotatable distal drive shaft and acoupling member of the first force/rotation transmitting/convertingassembly of FIG. 25 ;

FIG. 28 is a perspective view, with parts separated, of a trocarassembly of the first force/rotation transmitting/converting assembly ofFIG. 25 ;

FIG. 29 is a perspective view, of a distal end portion of the firstforce/rotation transmitting/converting assembly of FIG. 25 ,illustrating a support block thereof;

FIG. 30 is a perspective view, of a distal end portion of the firstforce/rotation transmitting/converting assembly of FIG. 25 , with thesupport block thereof shown in phantom;

FIG. 31 is a cross-sectional view as taken through 31-31 of FIG. 29 ;

FIG. 32 is a cross-sectional view as taken through 32-32 of FIG. 29 ;

FIG. 33 is a cross-sectional view as taken through 33-33 of FIG. 32 ;

FIG. 34 is a perspective view of the adapter assembly, shown partiallyin phantom, illustrating a second force/rotation transmitting/convertingassembly thereof;

FIG. 35 is a perspective view of the second force/rotationtransmitting/converting assembly of FIG. 34 ;

FIG. 36 is an enlarged view of the indicated area of detail of FIG. 35 ;

FIG. 37 is a perspective view, with parts separated, of a planetary gearset and staple driver, of the second force/rotationtransmitting/converting assembly of FIG. 34 ;

FIG. 38 is a cross-sectional view as taken through 38-38 of FIG. 24 ;

FIG. 39 is a perspective view of the adapter assembly, shown partiallyin phantom, illustrating a third force/rotation transmitting/convertingassembly thereof;

FIG. 40 is a perspective view of the third force/rotationtransmitting/converting assembly of FIG. 39 ;

FIG. 41 is an enlarged view of the indicated area of detail of FIG. 40 ;

FIG. 42 is a perspective view, with parts separated, of a planetary gearset and knife driver, of the third force/rotationtransmitting/converting assembly of FIG. 39 ;

FIG. 43 is a perspective view of a distal portion of the adapterassembly;

FIG. 44 is a further perspective view, with parts separated, of a distalportion of the adapter assembly;

FIG. 45 is a rear, perspective view of the internal components of thedistal end portion of the adapter assembly;

FIG. 46 is an enlarged view of the indicated area of detail of FIG. 45 ;

FIG. 47 is a front, perspective view of the internal components of thedistal end portion of the adapter assembly;

FIG. 48 is an enlarged view of the indicated area of detail of FIG. 47 ;

FIG. 49 is a front, perspective view of the internal components of amore distal end portion of the adapter assembly of FIGS. 45-48 ;

FIG. 50 is a front, perspective view, with parts separated, of theinternal components of the more distal end portion of the adapterassembly of FIG. 49 ;

FIG. 51 is a perspective view, with parts separated, of the distal endportion of the adapter assembly of FIGS. 45-50 ;

FIG. 52 is a perspective view of the distal end portion of the adapterassembly of FIGS. 45-51 , illustrating an electrical assembly thereof;

FIG. 53 is a perspective view of the electrical assembly of the adapterassembly of the present disclosure;

FIG. 54 is a perspective view of a strain gauge assembly of theelectrical assembly of FIGS. 52-53 ;

FIG. 55 is a cross-sectional view, as taken through 55-55 of FIG. 54 ;

FIG. 56 is a longitudinal, cross-sectional view of the more distal endportion of the adapter assembly illustrated in FIGS. 49 and 50 ;

FIG. 57 is a longitudinal, cross-sectional view of a knob assembly ofthe adapter assembly of the present disclosure;

FIG. 58 is a perspective view of a rotation assembly of the knobassembly;

FIG. 59 is a longitudinal, cross-sectional view of the rotation assemblyof FIG. 58 ;

FIG. 60 is a perspective, partial cross-sectional view, with partsseparated, of the rotation assembly of FIG. 58 ;

FIG. 61 is a perspective view of the rotation assembly, illustrating anoperation thereof;

FIG. 62 is a rear, perspective view of the adapter assembly,illustrating a rotation of the rotation assembly and a shaft assemblyrelative to a drive coupling assembly thereof;

FIG. 63 is a rear, perspective view of the adapter assembly,illustrating the adapter assembly in a non-rotated position thereof;

FIG. 64 is a cross-sectional view, as taken through 64-64 of FIG. 63 ;

FIG. 65 is a cross-sectional view, as taken through 64-64 of FIG. 63 ,illustrating the rotation of the rotation assembly and the shaftassembly relative to the drive coupling assembly;

FIG. 66 is a perspective view, with parts separated, of a reloadaccording to the present disclosure;

FIG. 67 is a longitudinal, cross-sectional view of the assembled reloadof FIG. 66 ;

FIG. 68 is a perspective view of an electrical connector of the reloadof FIGS. 66-67 ;

FIG. 69 is a cross-sectional view, as taken through 69-69 of FIG. 68 ;

FIG. 70 is a rear, perspective view of the reload of FIGS. 66-69 , witha release ring and a retaining ring illustrated separated therefrom;

FIG. 71 is a longitudinal, cross-sectional view, illustrating the reloadaligned with and separated from the more distal end portion of theadapter assembly;

FIG. 72 is a longitudinal, cross-sectional view, illustrating the reloadaligned and connected with the more distal end portion of the adapterassembly;

FIG. 73 is a front, perspective view of an anvil assembly of the presentdisclosure;

FIG. 74 is a rear, perspective view of the anvil assembly of FIG. 73 ;

FIG. 75 is a perspective view, with parts separated, of the anvilassembly of FIGS. 73 and 74 ;

FIG. 76 is a rear, perspective view of the reload and more distal endportion of the adapter assembly, illustrating a connection of anirrigation tube thereto;

FIG. 77 is a rear, perspective view of the reload and more distal endportion of the adapter assembly, illustrating the irrigation tubeseparated therefrom;

FIG. 78 is an enlarged view of the indicated area of detail of FIG. 77 ;

FIG. 79 is a perspective view of the irrigation tube;

FIG. 80 is an enlarged view of the indicated area of detail of FIG. 79 ;

FIG. 81 is an enlarged view of the indicated area of detail of FIG. 79 ;

FIGS. 82A-G illustrate a flow chart of a method for operating thehandheld surgical device of FIG. 1 according to an embodiment of thepresent disclosure;

FIG. 83 is a schematic diagram illustrating travel distance and speed ofthe anvil assembly and a corresponding motor during a clamping sequenceperformed by the handheld surgical device of FIG. 1 according to anembodiment of the present disclosure;

FIG. 84 is a schematic diagram illustrating travel distance and speed ofthe driver and a corresponding motor during a stapling sequenceperformed by the handheld surgical device of FIG. 1 according to anembodiment of the present disclosure;

FIG. 85 is a schematic diagram illustrating travel distance and speed ofthe knife assembly and a corresponding motor during a cutting sequenceperformed by the handheld surgical device of FIG. 1 according to anembodiment of the present disclosure;

FIG. 86 illustrates a flow chart of a method for controlled tissuecompression algorithm executed by the handheld surgical device of FIG. 1according to an embodiment of the present disclosure;

FIGS. 87A-B illustrate a flow chart of a method for a stapling algorithmexecuted by the handheld surgical device of FIG. 1 according to anembodiment of the present disclosure;

FIGS. 88A-B illustrate a flow chart of a method for a cutting algorithmexecuted by the handheld surgical device of FIG. 1 according to anembodiment of the present disclosure; and

FIG. 89 is a schematic diagram of the handheld surgical device, theadapter assembly, and the reload according to an embodiment of thepresent disclosure.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed surgical devices, and adapterassemblies for surgical devices and/or handle assemblies are describedin detail with reference to the drawings, in which like referencenumerals designate identical or corresponding elements in each of theseveral views. As used herein the term “distal” refers to that portionof the adapter assembly or surgical device, or component thereof,farther from the user, while the term “proximal” refers to that portionof the adapter assembly or surgical device, or component thereof, closerto the user.

A surgical device, in accordance with an embodiment of the presentdisclosure, is a handheld surgical device in the form of a poweredelectromechanical handle assembly configured for selective attachmentthereto of a plurality of different reloads, via a plurality ofrespective adapter assemblies, that are each configured for actuationand manipulation by the powered electromechanical handle assembly.

The surgical device includes a handle assembly 100 which is configuredfor selective connection with an adapter assembly 200, and, in turn,adapter assembly 200 is configured for selective connection with aselected reload 400 (of a plurality of reloads), which are configured toproduce a surgical effect on tissue of a patient.

As illustrated in FIGS. 1-11 , handle assembly 100 includes a powerhandle 101, and an outer shell housing 10 configured to selectivelyreceive and encase power handle 101. Outer shell housing 10 includes adistal half-section 10 a and a proximal half-section 10 b pivotablyconnected to distal half-section 10 a by a hinge 16 located along anupper edge of distal half-section 10 a and proximal half-section 10 b.When joined, distal and proximal half-sections 10 a, 10 b define a shellcavity 10 c therein in which power handle 101 is selectively situated.

Distal and proximal half-sections 10 a, 10 b of shell housing 10 aredivided along a plane that traverses a longitudinal axis “X” of adapterassembly 200.

Each of distal and proximal half-sections 10 a, 10 b of shell housing 10includes a respective upper shell portion 12 a, 12 b, and a respectivelower shell portion 14 a, 14 b. Lower shell portions 14 a, 14 b define asnap closure feature 18 for selectively securing lower shell portions 14a, 14 b to one another and for maintaining shell housing 10 in a closedcondition. Shell housing 10 includes right-side and left-side snapclosure features 18 a for further securing distal and proximalhalf-sections 10 a, 10 b of shell housing 10 to one another.

Distal half-section 10 a of shell housing 10 defines a connectingportion 20 configured to accept a corresponding drive coupling assembly210 of Adapter assembly 200. Specifically, distal half-section 10 a ofshell housing 10 has a recess 20 that receives a portion of drivecoupling assembly 210 of Adapter assembly 200 when Adapter assembly 200is mated to handle assembly 100.

Connecting portion 20 of distal half-section 10 a defines a pair ofaxially extending guide rails 20 a, 20 b projecting radially inward frominner side surfaces thereof. Guide rails 20 a, 20 b assist inrotationally orienting Adapter assembly 200 relative to handle assembly100 when Adapter assembly 200 is mated to handle assembly 100.

Connecting portion 20 of distal half-section 10 a defines threeapertures 22 a, 22 b, 22 c formed in a distally facing surface thereofand which are arranged in a common plane or line with one another.Connecting portion 20 of distal half-section 10 a also defines anelongate slot 24 (to contain connector 66, see FIG. 3 ) also formed inthe distally facing surface thereof.

Connecting portion 20 of distal half-section 10 a further defines afemale connecting feature 26 (see FIG. 2 ) formed in a surface thereof.Female connecting feature 26 selectively engages with a male connectingfeature of Adapter assembly 200, as will be described in greater detailbelow.

Distal half-section 10 a of shell housing 10 supports a distal facingtoggle control button 30. Toggle control button 30 is capable of beingactuated in a left, right, up, and down direction upon application of acorresponding force thereto or a depressive force thereto.

Distal half-section 10 a of shell housing 10 supports a right-side pairof control buttons 32 a, 32 b (see FIG. 3 ); and a left-side pair ofcontrol button 34 a, 34 b (see FIG. 2 ). Right-side control buttons 32a, 32 b and left-side control buttons 34 a, 34 b are capable of beingactuated upon application of a corresponding force thereto or adepressive force thereto.

Proximal half-section 10 b of shell housing 10 supports a right-sidefire button 36 a (see FIG. 3 ) and a left-side fire button 36 b (seeFIG. 2 ). Right-side fire button 36 a and left-side fire button 36 b arecapable of being actuated upon application of a corresponding forcethereto or a depressive force thereto.

Distal half-section 10 a and proximal half-section 10 b of shell housing10 are fabricated from a polycarbonate, and are clear or transparent ormay be overmolded.

With reference to FIGS. 5-11 , handle assembly 100 includes an insertionguide 50 that is configured and shaped to seat on and entirely surrounda distal facing edge 10 d (FIGS. 3 and 9 ) of proximal half-section 10b. Insertion guide 50 includes a body portion 52 defining a centralopening therein, and a hand/finger grip tab 54 extending from a bottomof body portion 52.

In use, when body portion 52 of insertion guide 50 is seated on distalfacing edge 10 d of proximal half-section 10 b, the central opening ofinsertion guide 50 provides access to shell cavity 10 c of shell housing10 for insertion of a non-sterile power handle 101 of handle assembly100 into proximal half-section 10 b of sterile shell housing 10.

With reference to FIGS. 2-4 , shell housing 10 includes a sterilebarrier plate assembly 60 selectively supported in distal half-section10 a. Specifically, sterile barrier plate assembly 60 is disposed behindconnecting portion 20 of distal half-section 10 a and within shellcavity 10 c of shell housing 10. Plate assembly 60 includes a plate 62rotatably supporting three coupling shafts 64 a, 64 b, 64 c. Eachcoupling shaft 64 a, 64 b, 64 c extends from opposed sides of plate 62and has a tri-lobe transverse cross-sectional profile. Each couplingshaft 64 a, 64 b, 64 c extends through a respective aperture 22 b, 22 c,22 a of connecting portion 20 of distal half-section 10 a when sterilebarrier plate assembly 60 is disposed within shell cavity 10 c of shellhousing 10.

Plate assembly 60 further includes an electrical connector 66 supportedon plate 62. Electrical connector 66 extends from opposed sides of plate62. Each coupling shaft 64 a, 64 b, 64 c extends through respectiveaperture 22 a, 22 b, 22 c of connecting portion 20 of distalhalf-section 10 a of shell housing 10 when sterile barrier plateassembly 60 is disposed within shell cavity 10 c of shell housing 10.Electrical connector 66 includes a chip and defines a plurality ofcontact paths each including an electrical conduit for extending anelectrical connection across plate 62.

When plate assembly 60 is disposed within shell cavity 10 c of shellhousing 10, distal ends of coupling shaft 64 a, 64 b, 64 c and a distalend of pass-through connector 66 are disposed or situated withinconnecting portion 20 of distal half-section 10 a of shell housing 10,and electrically and/or mechanically engage respective correspondingfeatures of Adapter assembly 200, as will be described in greater detailbelow.

In operation, with a new and/or sterile shell housing 10 in an openconfiguration (e.g., distal half-section 10 a separated from proximalhalf-section 10 b, about hinge 16), and with insertion guide 50 in placeagainst the distal edge 10 d of proximal half-section 10 b of shellhousing 10, power handle 101 is inserted through the central opening ofinsertion guide 50 and into shell cavity 10 c of shell housing 10. Withpower handle 101 inserted into shell cavity 10 c of shell housing 10,insertion guide 50 is removed from proximal half-section 10 b and distalhalf-section 10 a is pivoted, about hinge 16, to a closed configurationfor shell housing 10. In the closed configuration, snap closure feature18 of lower shell portion 14 a of distal half-section 10 a engages snapclosure feature 18 of lower shell portion 14 b of proximal half-section10 b. Also, right-side and left-side snap closure features 18 a engageto further maintain shell housing 10 in the closed configuration.

In operation, following a surgical procedure, snap closure feature 18 oflower shell portion 14 a of distal half-section 10 a is disengaged fromsnap closure feature 18 of lower shell portion 14 b of proximalhalf-section 10 b, and right-side and left-side snap closure features 18a are disengaged, such that distal half-section 10 a may be pivoted,about hinge 16, away from proximal half-section 10 b to open shellhousing 10. With shell housing 10 open, power handle 101 is removed fromshell cavity 10 c of shell housing 10 (specifically from proximalhalf-section 10 b of shell housing 10), and shell housing 10 isdiscarded.

Power handle 101 is then disinfected and cleaned. Power handle 101 isnot to be submerged and is not to be sterilized.

Referring to FIGS. 3-6 and FIGS. 12-19 , handle assembly 100 includes apower handle 101. Power handle 101 includes an inner handle housing 110having a lower housing portion 104 and an upper housing portion 108extending from and/or supported on lower housing portion 104. Lowerhousing portion 104 and upper housing portion 108 are separated into adistal half-section 110 a and a proximal half-section 110 b connectableto distal half-section 110 a by a plurality of fasteners. When joined,distal and proximal half-sections 110 a, 110 b define an inner handlehousing 110 having an inner housing cavity 110 c therein in which apower-pack core assembly 106 is situated.

Power-pack core assembly 106 is configured to control the variousoperations of handle assembly 100, as will be set forth in additionaldetail below.

Distal half-section 110 a of inner handle housing 110 defines a distalopening 111 a therein which is configured and adapted to support acontrol plate 160 of power-pack core assembly 106. Control plate 160 ofpower handle 101 abuts against a rear surface of plate 62 of sterilebarrier plate assembly 60 of shell housing 10 when power handle 101 isdisposed within shell housing 10.

With reference to FIG. 12 , distal half-section 110 a of inner handlehousing 110 supports a distal toggle control interface 130 that is inoperative registration with distal toggle control button 30 of shellhousing 10. In use, when power handle 101 is disposed within shellhousing 10, actuation of toggle control button 30 exerts a force ontoggle control interface 130.

Distal half-section 110 a of inner handle housing 110 also supports aright-side pair of control interfaces 132 a, 132 b, and a left-side pairof control interfaces 134 a, 134 b. In use, when power handle 101 isdisposed within shell housing 10, actuation of one of the right-sidepair of control buttons 32 a, 32 b or the left-side pair of controlbutton 34 a, 34 b of distal half-section 10 a of shell housing 10 exertsa force on a respective one of the right-side pair of control interfaces132 a, 132 b or the left-side pair of control interfaces 134 a, 134 b ofdistal half-section 110 a of inner handle housing 110.

In use, control button 30, right-side fire button 36 a or the left-sidefire button 36 b, the right-side pair of control interfaces 132 a, 132b, and the left-side pair of control interfaces 134 a, 134 b of distalhalf-section 110 a of inner handle housing 110 will be deactivated orfail to function unless shell housing 10 has been validated.

Proximal half-section 110 b of inner handle housing 110 defines aright-side control aperture 136 a and a left-side control aperture 136b. In use, when power handle 101 is disposed within shell housing 10,actuation of one of the right-side fire button 36 a or the left-sidefire button 36 b of proximal half-section 10 b of shell housing 10extends the right-side fire button 36 a or the left-side fire button 36b into and across the right-side control aperture 136 a or the left-sidecontrol aperture 136 b of the proximal half-section 110 b of innerhandle housing 110.

With reference to FIGS. 12-19 , inner handle housing 110 provides ahousing in which power-pack core assembly 106 is situated. Power-packcore assembly 106 includes a battery circuit 140, a controller circuitboard 142 and a rechargeable battery 144 configured to supply power toany of the electrical components of handle assembly 100. Controllercircuit board 142 includes a motor controller circuit board 142 a, amain controller circuit board 142 b, and a first ribbon cable 142 cinterconnecting motor controller circuit board 142 a and main controllercircuit board 142 b.

Power-pack core assembly 106 further includes a display screen 146supported on main controller circuit board 142 b. Display screen 146 isvisible through a clear or transparent window 110 d (see FIGS. 12 and 17) provided in proximal half-section 110 b of inner handle housing 110.

Power-pack core assembly 106 further includes a first motor 152, asecond motor 154, and a third motor 156 each electrically connected tocontroller circuit board 142 and battery 144. Motors 152, 154, 156 aredisposed between motor controller circuit board 142 a and maincontroller circuit board 142 b. Each motor 152, 154, 156 includes arespective motor shaft 152 a, 154 a, 156 a extending therefrom. Eachmotor shaft 152 a, 154 a, 156 a has a tri-lobe transversecross-sectional profile for transmitting rotative forces or torque.

Each motor 152, 154, 156 is controlled by a respective motor controller.The motor controllers are disposed on motor controller circuit board 142a and are A3930/31K motor drivers from Allegro Microsystems, Inc. TheA3930/31K motor drivers are designed to control a 3-phase brushless DC(BLDC) motor with N-channel external power MOSFETs, such as the motors152, 154, 156. Each of the motor controllers is coupled to a maincontroller disposed on the main controller circuit board 142 b. The maincontroller is also coupled to memory, which is also disposed on the maincontroller circuit board 142 b. The main controller is an ARM Cortex M4processor from Freescale Semiconductor, Inc, which includes 1024kilobytes of internal flash memory. The main controller communicateswith the motor controllers through an FPGA, which provides control logicsignals (e.g., coast, brake, etc.). The control logic of the motorcontrollers then outputs corresponding energization signals to theirrespective motors 152, 154, 156 using fixed-frequency pulse widthmodulation (PWM).

Each motor 152, 154, 156 is supported on a motor bracket 148 such thatmotor shaft 152 a, 154 a, 156 a are rotatably disposed within respectiveapertures of motor bracket 148. As illustrated in FIGS. 16 and 19 ,motor bracket 148 rotatably supports three rotatable drive connectorsleeves 152 b, 154 b, 156 b that are keyed to respective motor shafts152 a, 154 a, 156 a of motors 152, 154, 156. Drive connector sleeves 152b, 154 b, 156 b non-rotatably receive proximal ends of respectivecoupling shaft 64 a, 64 b, 64 c of plate assembly 60 of shell housing10, when power handle 101 is disposed within shell housing 10. Driveconnector sleeves 152 b, 154 b, 156 b are each spring biased away fromrespective motors 152, 154, 156.

Rotation of motor shafts 152 a, 154 a, 156 a by respective motors 152,154, 156 function to drive shafts and/or gear components of Adapterassembly 200 in order to perform the various operations of handleassembly 100. In particular, motors 152, 154, 156 of power-pack coreassembly 106 are configured to drive shafts and/or gear components ofadapter assembly 200 in order to selectively extend/retract a trocarmember 274 of a trocar assembly 270 of adapter assembly 200; to,open/close reload 400 (when an anvil assembly 510 is connected to trocarmember 274 of trocar assembly 270), to fire an annular array of staplesof reload 400, and to fire an annular knife 444 of reload 400.

Motor bracket 148 also supports an electrical receptacle 149. Electricalreceptacle 149 is in electrical connection with main controller circuitboard 142 b by a second ribbon cable 142 d. Electrical receptacle 149defines a plurality of electrical slots for receiving respectiveelectrical contacts or blades extending from pass-through connector 66of plate assembly 60 of shell housing 10.

In use, when adapter assembly 200 is mated to handle assembly 100, eachof coupling shafts 64 a, 64 b, 64 c of plate assembly 60 of shellhousing 10 of handle assembly 100 couples with corresponding rotatableconnector sleeves 218, 222, 220 of adapter assembly 200 (see FIG. 22 ).In this regard, the interface between corresponding first coupling shaft64 a and first connector sleeve 218, the interface between correspondingsecond coupling shaft 64 b and second connector sleeve 222, and theinterface between corresponding third coupling shaft 64 c and thirdconnector sleeve 220 are keyed such that rotation of each of couplingshafts 64 a, 64 b, 64 c of handle assembly 100 causes a correspondingrotation of the corresponding connector sleeve 218, 222, 220 of adapterassembly 200.

The mating of coupling shafts 64 a, 64 b, 64 c of handle assembly 100with connector sleeves 218, 222, 220 of adapter assembly 200 allowsrotational forces to be independently transmitted via each of the threerespective connector interfaces. The coupling shafts 64 a, 64 b, 64 c ofhandle assembly 100 are configured to be independently rotated byrespective motors 152, 154, 156.

Since each of coupling shafts 64 a, 64 b, 64 c of handle assembly 100has a keyed and/or substantially non-rotatable interface with respectiveconnector sleeves 218, 222, 220 of adapter assembly 200, when adapterassembly 200 is coupled to handle assembly 100, rotational force(s) areselectively transferred from motors 152, 154, 156 of handle assembly 100to adapter assembly 200.

The selective rotation of coupling shaft(s) 64 a, 64 b, 64 c of handleassembly 100 allows handle assembly 100 to selectively actuate differentfunctions of reload 400. As will be discussed in greater detail below,selective and independent rotation of first coupling shaft 64 a ofhandle assembly 100 corresponds to the selective and independentextending/retracting of trocar member 274 of adapter assembly 200 and/orthe selective and independent opening/closing of reload 400 (when anvilassembly 510 is connected to trocar member 274). Also, the selective andindependent rotation of third coupling shaft 64 c of handle assembly 100corresponds to the selective and independent firing of an annular arrayof staples of reload 400. Additionally, the selective and independentrotation of second coupling shaft 64 b of handle assembly 100corresponds to the selective and independent firing of an annular knife444 of reload 400.

With reference to FIGS. 12-19 , power-pack core assembly 106 furtherincludes a switch assembly 170 supported within distal half-section 110a of inner handle housing 110, at a location beneath and in registrationwith toggle control interface 130, the right-side pair of controlinterfaces 132 a, 132 b, and the left-side pair of control interfaces134 a, 134 b. Switch assembly 170 includes a first set of fourpush-button switches 172 a-172 d arranged around stem 30 a of togglecontrol button 30 of outer shell housing 10 when power handle 101 isdisposed within outer shell housing 10. Switch assembly 170 alsoincludes a second pair of push-button switches 174 a, 174 b disposedbeneath right-side pair of control interfaces 132 a, 132 b of distalhalf-section 110 a of inner handle housing 110 when power handle 101 isdisposed within outer shell housing 10. Switch assembly 170 furtherincludes a third pair of push-button switches 176 a, 176 b disposedbeneath left-side pair of control interfaces 134 a, 134 b of distalhalf-section 110 a of inner handle housing 110 when power handle 101 isdisposed within outer shell housing 10.

Power-pack core assembly 106 includes a single right-side push-buttonswitch 178 a disposed beneath right-side control aperture 136 a ofproximal half-section 110 b of inner handle housing 110, and a singleleft-side push-button switch 178 b disposed beneath left-side controlaperture 136 b of proximal half-section 110 b of inner handle housing110. Push-button switches 178 a, 178 b are supported on controllercircuit board 142. Push-button switches 178 a, 178 b are disposedbeneath right-side fire button 36 a and left-side fire button 36 b ofproximal half-section 10 b of shell housing 10 when power handle 101 isdisposed within outer shell housing 10.

The actuation of push button switch 172 c of switch assembly 170 ofpower handle 101, corresponding to a downward actuation of togglecontrol button 30, causes controller circuit board 142 to provideappropriate signals to motor 152 to activate, to retract a trocar member274 of adapter assembly 200 and/or to close handle assembly 100 (e.g.,approximate anvil assembly 510 relative to reload 400).

The actuation of push button switch 172 a of switch assembly 170 ofpower handle 101, corresponding to an upward actuation of toggle controlbutton 30, causes controller circuit board 142 to activate, to advancetrocar member 274 of adapter assembly 200 and/or to open handle assembly100 (e.g., separate anvil assembly 510 relative to reload 400).

The actuation of fire switch 178 a or 178 b of power handle 101,corresponding to an actuation of right-side or left-side control button36 a, 36 b, causes controller circuit board 142 to provide appropriatesignals to motors 154 and 156 to activate, as appropriate, to firestaples of reload 400, and then to advance (e.g., fire) and retract anannular knife 444 of reload 400.

The actuation of switches 174 a, 174 b (by right-hand thumb of user) orswitches 176 a, 176 b (by left-hand thumb of user) of switch assembly170, corresponding to respective actuation of right-side pair of controlbuttons 32 a, 32 b or left-side pair of control button 34 a, 34 b,causes controller circuit board 142 to provide appropriate signals tomotor 152 to activate, to advance or retract trocar member 274 ofadapter assembly 200.

With reference to FIGS. 12 and 14 , power-pack core assembly 106 ofhandle assembly 100 includes a USB connector 180 supported on maincontroller circuit board 142 b of controller circuit board 142. USBconnector 180 is accessible through control plate 160 of power-pack coreassembly 106. When power handle 101 is disposed within outer shellhousing 10, USB connector 180 is covered by plate 62 of sterile barrierplate assembly 60 of shell housing 10.

As illustrated in FIG. 1 and FIGS. 20-65 , handle assembly 100 isconfigured for selective connection with adapter assembly 200, and, inturn, adapter assembly 200 is configured for selective connection withreload 400.

Adapter assembly 200 is configured to convert a rotation of couplingshaft(s) 64 a, 64 b, 64 c of handle assembly 100 into axial translationuseful for advancing/retracting trocar member 274 of adapter assembly200, for opening/closing handle assembly 100 (when anvil assembly 510 isconnected to trocar member 274), for firing staples of reload 400, andfor firing annular knife 444 of reload 400, as illustrated in FIG. 22 ,and as will be described in greater detail below.

Adapter assembly 200 includes a first drive transmitting/convertingassembly for interconnecting first coupling shaft 64 a of handleassembly 100 and an anvil assembly 510, wherein the first drivetransmitting/converting assembly converts and transmits a rotation offirst coupling shaft 64 a of handle assembly 100 to an axial translationof trocar member 274 of trocar assembly 270, and in turn, the anvilassembly 510, which is connected to trocar member 274, to open/closehandle assembly 100.

Adapter assembly 200 includes a second drive transmitting/convertingassembly for interconnecting third coupling shaft 64 c of handleassembly 100 and a second axially translatable drive member of reload400, wherein the second drive transmitting/converting assembly convertsand transmits a rotation of third coupling shaft 64 c of handle assembly100 to an axial translation of an outer flexible band assembly 255 ofadapter assembly 200, and in turn, a driver adapter 432 of a stapledriver assembly 430 of reload 400 to fire staples from a staplecartridge 420 of reload 400 and against anvil assembly 510.

Adapter assembly 200 includes a third drive transmitting/convertingassembly for interconnecting second coupling shaft 64 b of handleassembly 100 and a third axially translatable drive member of reload400, wherein the third drive transmitting/converting assembly convertsand transmits a rotation of second coupling shaft 64 b of handleassembly 100 to an axial translation of an inner flexible band assembly265 of adapter assembly 200, and in turn, a knife assembly 440 of reload400 to fire annular knife 444 against anvil assembly 510.

Turning now to FIGS. 20-24 , adapter assembly 200 includes an outer knobhousing 202 and an outer tube 206 extending from a distal end of knobhousing 202. Knob housing 202 and outer tube 206 are configured anddimensioned to house the components of adapter assembly 200. Knobhousing 202 includes a drive coupling assembly 210 which is configuredand adapted to connect to connecting portion 108 of handle housing 102of handle assembly 100.

Adapter assembly 200 is configured to convert a rotation of either offirst, second or third coupling shafts 64 a, 64 b, 64 c, respectively,of handle assembly 100, into axial translations useful for operatingtrocar assembly 270 of adapter assembly 200, anvil assembly 510, and/orstaple driver assembly 430 or knife assembly 440 of reload 400, as willbe described in greater detail below.

As illustrated in FIGS. 57-61 , adapter assembly 200 includes a proximalinner housing member 204 disposed within knob housing 202. Inner housingmember 204 rotatably supports a first rotatable proximal drive shaft212, a second rotatable proximal drive shaft 214, and a third rotatableproximal drive shaft 216 therein. Each proximal drive shaft 212, 214,216 functions as a rotation receiving member to receive rotationalforces from respective coupling shafts 64 a, 64 c and 64 b of handleassembly 100, as described in greater detail below.

As described briefly above, drive coupling assembly 210 of adapterassembly 200 is also configured to rotatably support first, second andthird connector sleeves 218, 222 and 220, respectively, arranged in acommon plane or line with one another. Each of connector sleeves 218,220, 222 is configured to mate with respective first, second and thirdcoupling shafts 64 a, 64 c and 64 b of handle assembly 100, as describedabove. Each of connector sleeves 218, 220, 222 is further configured tomate with a proximal end of respective first, second and third proximaldrive shafts 212, 214, 216 of adapter assembly 200.

Drive coupling assembly 210 of adapter assembly 200 also includes, asillustrated in FIGS. 26, 34, 35 and 40 , a first, a second and a thirdbiasing member 224, 226 and 228 disposed distally of respective first,second and third connector sleeves 218, 222, 220. Each of biasingmembers 224, 226 and 228 is disposed about respective first, second andthird rotatable proximal drive shaft 212, 216 and 214. Biasing members224, 226 and 228 act on respective connector sleeves 218, 222 and 220 tohelp maintain connector sleeves 218, 222 and 220 engaged with the distalend of respective coupling shafts 64 a, 64 b and 64 c of handle assembly100 when adapter assembly 200 is connected to handle assembly 100.

In particular, first, second and third biasing members 224, 226 and 228function to bias respective connector sleeves 218, 222 and 220 in aproximal direction. In this manner, during connection of handle assembly100 to adapter assembly 200, if first, second and or third connectorsleeves 218, 222 and/or 220 is/are misaligned with coupling shafts 64 a,64 b and 64 c of handle assembly 100, first, second and/or third biasingmember(s) 224, 226 and/or 228 are compressed. Thus, when handle assembly100 is operated, coupling shafts 64 a, 64 c and 64 b of handle assembly100 will rotate and first, second and/or third biasing member(s) 224,228 and/or 226 will cause respective first, second and/or thirdconnector sleeve(s) 218, 220 and/or 222 to slide back proximally,effectively connecting coupling shafts 64 a, 64 c and 64 b of handleassembly 100 to first, second and/or third proximal drive shaft(s) 212,214 and 216 of drive coupling assembly 210.

As briefly mentioned above, adapter assembly 200 includes a first, asecond and a third force/rotation transmitting/converting assembly 240,250, 260, respectively, disposed within inner housing member 204 andouter tube 206. Each force/rotation transmitting/converting assembly240, 250, 260 is configured and adapted to transmit or convert arotation of a first, second and third coupling shafts 64 a, 64 c and 64b of handle assembly 100 into axial translations to effectuate operationof trocar assembly 270 of adapter assembly 200, and of staple driverassembly 430 or knife assembly 440 of reload 400.

As shown in FIGS. 25-28 , first force/rotation transmitting/convertingassembly 240 includes first rotatable proximal drive shaft 212, asdescribed above, a second rotatable proximal drive shaft 281, arotatable distal drive shaft 282, and a coupling member 286, each ofwhich are supported within inner housing member 204, drive couplingassembly 210 and/or an outer tube 206 of adapter assembly 200. Firstforce/rotation transmitting/converting assembly 240 functions toextend/retract trocar member 274 of trocar assembly 270 of adapterassembly 200, and to open/close handle assembly 100 (when anvil assembly510 is connected to trocar member 274).

First rotatable proximal drive shaft 212 includes a non-circular orshaped proximal end portion configured for connection with firstconnector 218 which is connected to respective first coupling shaft 64 aof handle assembly 100. First rotatable proximal drive shaft 212includes a non-circular recess formed therein which is configured to keywith a respective complimentarily shaped proximal end portion 281 a ofsecond rotatable proximal drive shaft 281. Second rotatable proximaldrive shaft 281 includes a distal end portion 281 b defining anoversized recess therein which is configured to receive a proximal endportion 282 a of first rotatable distal drive shaft 282. Proximal endportion 282 a of first rotatable distal drive shaft 282 is pivotallysecured within the recess in distal end 281 b of second rotatableproximal drive shaft 281 by a pin 283 a received through the oversizedrecess in distal end portion 281 b of second rotatable proximal driveshaft 281.

First rotatable distal drive shaft 282 includes a proximal end portion282 a, and a distal end portion 282 b which is pivotally secured withina recess of coupling member 286. Distal end portion 282 b of firstrotatable distal drive shaft 282 is pivotally secured within a recess ina proximal end of coupling member 286 by a pin 283 b received throughthe recess in the proximal end portion of coupling member 286. Proximaland distal end portions 282 a, 282 b of first rotatable distal driveshaft 282 define oversized openings for receiving pins 283 a, 283 b,respectively.

Coupling member 286 includes a proximal end 286 a defining a recess 286c for receiving distal end portion 282 b of first rotatable distal driveshaft 282, a distal end 286 b defining a recess 286 d for operablyreceiving a non-circular stem 276 c on proximal end 276 a of a drivescrew 276 of trocar assembly 270.

First force/rotation transmitting/converting assembly 240 furtherincludes a trocar assembly 270 removably supported in a distal end ofouter tube 206. Trocar assembly 270 includes an outer housing 272, atrocar member 274 slidably disposed within tubular outer housing 272,and a drive screw 276 operably received within trocar member 274 foraxially moving trocar member 274 relative to tubular housing 272. Inparticular, trocar member 274 includes a proximal end 274 a having aninner threaded portion which engages a threaded distal portion 276 b ofdrive screw 276. Trocar member 274 further includes at least onelongitudinally extending flat formed in an outer surface thereof whichmates with a corresponding flat formed in tubular housing 272 therebyinhibiting rotation of trocar member 274 relative to tubular housing 272as drive screw 276 is rotated. A distal end 274 b of trocar member 274is configured to selectively engage anvil assembly 510 (FIGS. 73-75 ).

Tubular housing 272 of trocar assembly 270 is axially and rotationallyfixed within outer tube 206 of adapter assembly 200. Tubular housing 272defines a pair of radially opposed, and radially oriented openings 272 awhich are configured and dimensioned to cooperate with a pair of lockpins 275 c of a trocar assembly release mechanism 275. With reference toFIGS. 29-33 , adapter assembly 200 includes a support block 292 fixedlydisposed within outer tube 206. Support block 292 is disposed proximalof a connector sleeve 290 and proximal of a strain sensor 320 a of astrain gauge assembly 320, as described in greater detail below. Thepair of lock pins 275 c extend through support block 292 and intotubular housing 272 of trocar assembly 270 to connect trocar assembly270 to adapter assembly 200.

As illustrated in FIGS. 29-33 , trocar assembly release mechanism 275includes a release button 275 a pivotally supported on support block 292and in outer tube 206. Release button 275 a is spring biased to alocked/extended condition. Trocar assembly release mechanism 275 furtherincludes a spring clip 275 b connected to release button 275 a, whereinspring clip 275 b includes a pair of legs that extend through supportblock 292 and transversely across trocar assembly 270. Each of the pairof legs of spring clip 275 b extends through a respective lock pin 275 cwhich is slidably disposed within a respective radial opening 272 a oftubular housing 272 and radial opening 292 a of support block 292 (seeFIG. 31 ).

In use, when release button 275 a is depressed (e.g., in a radiallyinward direction, FIG. 33 ), release button 275 a moves spring clip 275b transversely relative to trocar assembly 270. As spring clip 275 b ismoved transversely relative to trocar assembly 270, the pair of legs ofspring clip 275 b translate through the pair of lock pins 275 c suchthat a goose-neck in each leg acts to cam and urge the pair of lock pins275 c radially outward. Each of the pair of lock pins 275 c is urgedradially outward by a distance sufficient that each of the pair of lockpins 275 c clears respective opening 272 a of tubular housing 272. Withthe pair of lock pins 275 c free and clear of tubular housing 272,trocar assembly 270 may be axially withdrawn from within the distal endof outer tube 206 of adapter assembly 200.

In operation, as first rotatable proximal drive shaft 212 is rotated,due to a rotation of first connector sleeve 218, as a result of therotation of first coupling shaft 64 a of handle assembly 100, secondrotatable distal drive shaft 281 is caused to be rotated. Rotation ofsecond rotatable distal drive shaft 281 results in contemporaneousrotation of first rotatable distal drive shaft 282. Rotation of firstrotatable distal drive shaft 282 causes contemporaneous rotation ofcoupling member 286, which, in turn, causes contemporaneous rotation ofdrive screw 276 of trocar assembly 270. As drive screw 276 is rotatedwithin and relative to trocar member 274, engagement of the innerthreaded portion of trocar member 274 with threaded distal portion 276 bof drive screw 276 causes axial translation of trocar member 274 withintubular housing 272 of trocar assembly 270. Specifically, rotation ofdrive screw 276 in a first direction causes axial translation of trocarmember 274 in a first direction (e.g., extension of trocar assembly 270of handle assembly 100), and rotation of drive screw 276 in a seconddirection causes axial translation of trocar member 274 in a seconddirection (e.g., retraction of trocar assembly 270 of handle assembly100).

When anvil assembly 510 is connected to trocar member 274, as will bedescribed in detail below, the axial translation of trocar member 274 inthe first direction results in an opening of reload 400, and the axialtranslation of trocar member 274 in the second direction results in aclosing of reload 400.

Forces during an actuation or trocar member 274 or a closing of reload400 may be measured by strain sensor 320 a of strain gauge assembly 320in order to:

-   -   determine a presence and proper engagement of trocar assembly        270 in adapter assembly 200;    -   determine a presence of anvil assembly 510 during calibration;    -   determine misalignment of the splines of trocar member 274 with        longitudinally extending ridges 416 of reload 400;    -   determine a re-clamping of a previously tiled anvil assembly        510;    -   determine a presence of obstructions during clamping or closing        of reload 400;    -   determine a presence and connection of anvil assembly 510 with        trocar member 274;    -   monitor and control a compression of tissue disposed within        reload 400;    -   monitor a relaxation of tissue, over time, clamped within reload        400;    -   monitor and control a firing of staples from reload 400;    -   detect a presence of staples in reload 400;    -   monitors forces during a firing and formation of the staples as        the staples are being ejected from reload 400;    -   optimize formation of the staples (e.g., staple crimp height) as        the staples are being ejected from reload 400 for different        indications of tissue;    -   monitor and control a firing of annular knife 444 of reload 400;    -   monitor and control a completion of the firing and cutting        procedure; and    -   monitor a maximum firing force and control the firing and        cutting procedure to protect against exceeding a predetermined        maximum firing force.

In operation, strain sensor 320 a of strain gauge assembly 320 ofadapter assembly 200 measures and monitors the retraction of trocarmember 274, as described above. During the closing of reload 400, if andwhen head assembly 512 of anvil assembly 510 contacts tissue, anobstruction, staple cartridge 420 or the like, a reaction force isexerted on head assembly 512 which is in a generally distal direction.This distally directed reaction force is communicated from head assembly512 to center rod assembly 514 of anvil assembly 510, which in turn iscommunicated to trocar assembly 270. Trocar assembly 270 thencommunicates the distally directed reaction force to the pair of pins275 c of trocar assembly release mechanism 275, which in turn thencommunicate the reaction force to support block 292. Support block 292then communicates the distally directed reaction force to strain sensor320 a of strain gauge assembly 320.

Strain sensor 320 a of strain gauge assembly 320 is a device configuredto measure strain (a dimensionless quantity) on an object that it isadhered to (e.g., support block 292), such that, as the object deforms,a metallic foil of the strain sensor 320 a is also deformed, causing anelectrical resistance thereof to change, which change in resistance isthen used to calculate loads experienced by trocar assembly 270.

Strain sensor 320 a of strain gauge assembly 320 then communicatessignals to main controller circuit board 142 b of power-pack coreassembly 106 of handle assembly 100. Graphics are then displayed ondisplay screen 146 of power-pack core assembly 106 of handle assembly100 to provide the user with real-time information related to the statusof the firing of handle assembly 100.

With reference to FIGS. 34-38 , second force/rotationtransmitting/converting assembly 250 of adapter assembly 200 includessecond proximal drive shaft 214, as described above, a first couplingshaft 251, a planetary gear set 252, a staple lead screw 253, and astaple driver 254, each of which are supported within inner housingmember 204, drive coupling assembly 210 and/or an outer tube 206 ofadapter assembly 200. Second force/rotation transmitting/convertingassembly 250 functions to fire staples of reload 400 for formationagainst anvil assembly 510.

Second rotatable proximal drive shaft 214 includes a non-circular orshaped proximal end portion configured for connection with secondconnector or coupler 220 which is connected to respective secondcoupling shaft 64 c of handle assembly 100. Second rotatable proximaldrive shaft 214 further includes a distal end portion 214 b having aspur gear non-rotatably connected thereto.

First coupling shaft 251 of second force/rotationtransmitting/converting assembly 250 includes a proximal end portion 251a having a spur gear non-rotatably connected thereto, and a distal endportion 251 b having a spur gear non-rotatably connected thereto. Thespur gear at the proximal end portion 251 a of first coupling shaft 251is in meshing engagement with the spur gear at the distal end portion214 b of the second rotatable proximal drive shaft 214.

Planetary gear set 252 of second force/rotation transmitting/convertingassembly 250 includes a first cannulated sun gear 252 a, a first set ofplanet gears 252 b, a ring gear 252 c, a second set of planet gears 252d, and a second cannulated sun gear 252 e. First sun gear 252 a is inmeshing engagement with the spur gear at the distal end portion 251 b offirst coupling shaft 251. The first set of planet gears 252 b areinterposed between, and are in meshing engagement with, first sun gear252 a and ring gear 252 c. The second set of planet gears 252 d areinterposed between, and are in meshing engagement with, second sun gear252 e and ring gear 252 c. Ring gear 252 c is non-rotatably supported inouter tube 206 of adapter assembly 200.

Planetary gear set 252 of second force/rotation transmitting/convertingassembly 250 includes a washer 252 f disposed within ring gear 252 c,and between the first set of planet gears 252 b and the second set ofplanet gears 252 d. The first set of planet gears 252 b are rotatablysupported radially about washer 252 f, and second sun gear 252 e isnon-rotatably connected to a center of washer 252 f.

Staple lead screw 253 of second force/rotation transmitting/convertingassembly 250 includes a proximal flange 253 a and a distal threadedportion 253 b extending from flange 253 a. Staple lead screw 253 definesa lumen 253 c therethrough. The second set of planet gears 252 d arerotatably supported radially about proximal flange 253 a of staple leadscrew 253.

Staple driver 254 of second force/rotation transmitting/convertingassembly 250 includes a central threaded lumen 254 a extendingtherethrough and is configured and dimensioned to support distalthreaded portion 253 b of staple lead screw 253 therein. Staple driver254 includes a pair of tabs 254 b projecting radially from an outersurface thereof, and which are configured for connection to outerflexible band assembly 255 of adapter assembly 200, as will be describedin greater detail below.

With reference now to FIGS. 34, 35 and 43-51 , second force/rotationtransmitting/converting assembly 250 of adapter assembly 200 includes anouter flexible band assembly 255 secured to staple driver 254. Outerflexible band assembly 255 includes first and second flexible bands 255a, 255 b laterally spaced and connected at proximal ends thereof to asupport ring 255 c and at distal ends thereof to a proximal end of asupport base 255 d. Each of first and second flexible bands 255 a, 255 bis attached to support ring 255 c and support base 255 d.

Outer flexible band assembly 255 further includes first and secondconnection extensions 255 e, 255 f extending proximally from supportring 255 c. First and second connection extensions 255 e, 255 f areconfigured to operably connect outer flexible band assembly 255 tostaple driver 254 of second force/rotation transmitting/convertingassembly 250. In particular, each of first and second connectionextensions 255 e, 255 f defines an opening configured to receive arespective tab 254 b of staple driver 254. Receipt of tabs 254 b ofstaple driver 254 within the openings of respective first and secondconnection extensions 255 e, 255 f secures outer flexible band assembly255 to staple driver 254 of second force/rotationtransmitting/converting assembly 250.

Support base 255 d extends distally from flexible bands 255 a, 255 b andis configured to selectively contact driver adapter 432 of staple driverassembly 430 of reload 400.

Flexible bands 255 a, 255 b are fabricated from stainless steel 301 halfhard and are configured to transmit axial pushing forces along a curvedpath.

Second force/rotation transmitting/converting assembly 250 and outerflexible band assembly 255 are configured to receive first rotatableproximal drive shaft 212, first rotatable distal drive shaft 282, andtrocar assembly 270 of first force/rotation transmitting/convertingassembly 240 therethrough. Specifically, first rotatable proximal driveshaft 212 is non-rotatably connected to second rotatable proximal driveshaft 281 which in turn is rotatably disposed within and through firstcannulated sun gear 252 a of first planetary gear set 252, secondcannulated sun gear 252 e of planetary gear set 252, staple lead screw253, and staple driver 254.

Second force/rotation transmitting/converting assembly 250 and outerflexible band assembly 255 are also configured to receive thirdforce/rotation transmitting/converting assembly 260 therethrough.Specifically, as described below, inner flexible band assembly 265 isslidably disposed within and through outer flexible band assembly 255.

First rotatable distal drive shaft 282 of first force/rotationtransmitting/converting assembly 240 is rotatably disposed withinsupport base 255 d of outer flexible band assembly 255, while trocarmember 274 of trocar assembly 270 of first force/rotationtransmitting/converting assembly 240 is slidably disposed within supportbase 255 d of outer flexible band assembly 255.

Outer flexible band assembly 255 is also configured to receive innerflexible band assembly 265 therethrough.

In operation, as second rotatable proximal drive shaft 214 is rotateddue to a rotation of second connector sleeve 220, as a result of therotation of the second coupling shaft 64 c of handle assembly 100, firstcoupling shaft 251 is caused to be rotated, which in turn causes firstcannulated sun gear 252 a to rotate. Rotation of first cannulated sungear 252 a, results in contemporaneous rotation of the first set ofplanet gears 252 b, which in turn causes washer 252 f tocontemporaneously rotate second cannulated sun gear 252 e. Rotation ofsecond cannulated sun gear 252 e, results in contemporaneous rotation ofthe second set of planet gears 252 d, which in turn causescontemporaneous rotation of staple lead screw 253. As staple lead screw253 is rotated, staple driver 254 is caused to be axially translated,which in turn causes outer flexible band assembly 255 to be axiallytranslated. As outer flexible band assembly 255 is axially translated,support base 255 d presses against driver adapter 432 of staple driverassembly 430 of reload 400 to distally advance driver 434 and firestaples “S” (FIG. 67 ) of reload 400 against anvil assembly 510 forformation of staples “S” in underlying tissue.

With reference to FIGS. 39-42 and 45-51 , third force/rotationtransmitting/converting assembly 260 of adapter assembly 200 includesthird proximal drive shaft 216, as described above, a second couplingshaft 261, a planetary gear set 262, a knife lead screw 263, and a knifedriver 264, each of which are supported within inner housing member 204,drive coupling assembly 210 and/or an outer tube 206 of adapter assembly200. Third force/rotation transmitting/converting assembly 260 functionsto fire knife of reload 400.

Third rotatable proximal drive shaft 216 includes a non-circular orshaped proximal end portion configured for connection with thirdconnector or coupler 222 which is connected to respective third couplingshaft 64 b of handle assembly 100. Third rotatable proximal drive shaft216 further includes a distal end portion 216 b having a spur gearnon-rotatably connected thereto.

Second coupling shaft 261 of third force/rotationtransmitting/converting assembly 260 includes a proximal end portion 261a having a spur gear non-rotatably connected thereto, and a distal endportion 261 b having a spur gear non-rotatably connected thereto. Thespur gear at the proximal end portion 261 a of second coupling shaft 261is in meshing engagement with the spur gear at the distal end portion216 b of the third rotatable proximal drive shaft 216.

Planetary gear set 262 of third force/rotation transmitting/convertingassembly 260 includes a first cannulated sun gear 262 a, a first set ofplanet gears 262 b, a ring gear 262 c, a second set of planet gears 262d, and a second cannulated sun gear 262 e. First sun gear 262 a isnon-rotatably supported on a distal end portion of a hollow shaft 269.Hollow shaft 269 includes a spur gear 269 a non-rotatably supported on aproximal end thereof. Spur gear 269 a of hollow shaft 269 is in meshingengagement with the spur gear at the distal end portion 261 b of secondcoupling shaft 261. The first set of planet gears 262 b are interposedbetween, and are in meshing engagement with, first sun gear 262 a andring gear 262 c. The second set of planet gears 262 d are interposedbetween, and are in meshing engagement with, second sun gear 262 e andring gear 262 c. Ring gear 262 c is non-rotatably supported in outertube 206 of adapter assembly 200.

Planetary gear set 262 of third force/rotation transmitting/convertingassembly 260 includes a washer 262 f disposed within ring gear 262 c,and between the first set of planet gears 262 b and the second set ofplanet gears 262 d. The first set of planet gears 262 b are rotatablysupported radially about washer 262 f, and second sun gear 262 e isnon-rotatably connected to a center of washer 262 f.

Knife lead screw 263 of second force/rotation transmitting/convertingassembly 260 includes a proximal flange 263 a and a distal threadedportion 263 b extending from flange 263 a. Knife lead screw 263 definesa lumen 263 c therethrough. The second set of planet gears 262 d arerotatably supported radially about proximal flange 263 a of knife leadscrew 263.

Knife driver 264 of second force/rotation transmitting/convertingassembly 260 includes a central threaded lumen 264 a extendingtherethrough and is configured and dimensioned to support distalthreaded portion 263 b of knife lead screw 263 therein. Knife driver 264includes a pair of tabs 264 b projecting radially from an outer surfacethereof, and which are configured for connection to inner flexible bandassembly 265 of adapter assembly 200, as will be described in greaterdetail below.

With reference now to FIGS. 39-42 , third force/rotationtransmitting/converting assembly 260 of adapter assembly 200 includes aninner flexible band assembly 265 secured to knife driver 264. Innerflexible band assembly 265 includes first and second flexible bands 265a, 265 b laterally spaced and connected at proximal ends thereof to asupport ring 265 c and at distal ends thereof to a proximal end of asupport base 265 d. Each of first and second flexible bands 265 a, 265 bare attached to support ring 265 c and support base 265 d. Innerflexible band assembly 265 is configured to receive first rotatableproximal drive shaft 212, first rotatable distal drive shaft 282, andtrocar assembly 270 of first force/rotation transmitting/convertingassembly 240 therethrough.

Inner flexible band assembly 265 further includes first and secondconnection extensions 265 e, 265 f extending proximally from supportring 265 c. First and second connection extensions 265 e, 265 f areconfigured to operably connect inner flexible band assembly 265 to knifedriver 264 of third force/rotation transmitting/converting assembly 260.In particular, each of first and second connection extensions 265 e, 265f defines an opening configured to receive a respective tab 264 b ofknife driver 264. Receipt of tabs 264 b of knife driver 264 within theopenings of respective first and second connection extensions 265 e, 265f secures inner flexible band assembly 265 to knife driver 264 of thirdforce/rotation transmitting/converting assembly 260.

Support base 265 d extends distally from flexible bands 265 a, 265 b andis configured to connect with knife carrier 442 of knife assembly 440 ofreload 400.

Flexible bands 265 a, 265 b are fabricated from stainless steel 301 halfhard and are configured to transmit axial pushing forces along a curvedpath.

Third force/rotation transmitting/converting assembly 260 and innerflexible band assembly 265 are configured to receive first rotatableproximal drive shaft 212, first rotatable distal drive shaft 282, andtrocar assembly 270 of first force/rotation transmitting/convertingassembly 240 therethrough. Specifically, first rotatable proximal driveshaft 212 is rotatably disposed within and through hollow shaft 269,first cannulated sun gear 262 a of first planetary gear set 262, secondcannulated sun gear 262 e of planetary gear set 262, knife lead screw263, and knife driver 264.

First rotatable distal drive shaft 282 of first force/rotationtransmitting/converting assembly 240 is also rotatably disposed withinsupport base 265 d of inner flexible band assembly 265, while trocarmember 274 of trocar assembly 270 of first force/rotationtransmitting/converting assembly 240 is slidably disposed within supportbase 265 d of inner flexible band assembly 265.

In operation, as third rotatable proximal drive shaft 216 is rotated dueto a rotation of third connector sleeve 222, as a result of the rotationof the third coupling shaft 64 b of handle assembly 100, second couplingshaft 261 is caused to be rotated, which in turn causes hollow shaft 269to rotate. Rotation of hollow shaft 269 results in contemporaneousrotation of the first set of planet gears 262 b, which in turn causeswasher 262 f to rotate second cannulated sun gear 262 e. Rotation ofsecond cannulated sun gear 262 e causes contemporaneous rotation of thesecond set of planet gears 262 d, which in turn causes knife lead screw263 to rotate. As knife lead screw 263 is rotated, knife driver 264 iscaused to be axially translated, which in turn causes inner flexibleband assembly 265 to be axially translated. As inner flexible bandassembly 265 is axially translated, support base 265 d presses againstknife carrier 442 of reload 400 to distally advance knife carrier 442and fire annular knife 444 of reload 400 against anvil assembly 510 forcutting of tissue clamped in reload 400.

Turning now to FIGS. 21-24 , adapter assembly 200 includes an outer tube206 extending from knob housing 202. As mentioned above, outer tube 206is configured to support first, second and third force/rotationtransmitting/converting assembly 240, 250, 260, respectively. Adapterassembly 200 further includes a frame assembly 230 supported in outertube 206. Frame assembly 230 is configured to support and guide flexiblebands 255 a, 255 b of outer flexible band assembly 255, and flexiblebands 265 a, 265 b of inner flexible band assembly 265, as flexiblebands 255 a, 255 b, 265 a, 265 b are axially translated through outertube 206.

Frame assembly 230 includes first and second proximal spacer members 232a, 232 b, and first and second distal spacer members 234 a, 234 b. Whensecured together, first and second proximal spacer members 232 a, 232 bdefine a pair of inner longitudinal slots 234 c for slidably receivingfirst and second flexible bands 265 a, 265 b of inner flexible bandassembly 265 and a pair of outer longitudinal slots 234 d for slidablyreceiving first and second flexible bands 255 a, 255 b of outer flexibleband assembly 255. First and second proximal spacer members 232 a, 232 bfurther define a longitudinal passage therethrough for receipt of firstforce/rotation transmitting/converting assembly 240 and trocar assembly270.

First and second distal spacer members 234 a, 234 b define a pair ofinner slots 234 c for slidably receiving first and second flexible bands265 a, 265 b of inner flexible band assembly 265 and a pair of outerslots 234 d for slidably receiving first and second flexible bands 255a, 255 b of outer flexible band assembly 255. First and second distalspacer members 234 a, 234 b further define a longitudinal passagetherethrough for receipt of first force/rotation transmitting/convertingassembly 240, and trocar assembly 270.

First and second proximal spacer members 232 a, 232 b and first andsecond distal spacer members 234 a, 234 b are formed of plastic toreduce friction with flexible bands 255 a, 255 b of outer flexible bandassembly 255, and flexible bands 265 a, 265 b of inner flexible bandassembly 265.

With reference now to FIGS. 44-50 , frame assembly 230 further includesa seal member 235. Seal member 235 engages outer tube 206, inner andouter flexible bands 255 a, 255 b and 265 a, 265 b of respective innerand outer flexible band assemblies 255, 265 and trocar assembly 270, andwiring extending therethrough, in a sealing manner. In this manner, sealmember 235 operates to provide a fluid tight seal through between thedistal end and the proximal end of outer tube 206.

Adapter assembly 200 further includes a connector sleeve 290 fixedlysupported at a distal end of outer tube 206. Connector sleeve 290 isconfigured to selectively secure securing reload 400 to adapter assembly200, as will be described in greater detail below. Connector sleeve 290is also configured to be disposed about distal ends of outer and innerflexible assemblies 255, 265 and trocar assembly 270. In particular, aproximal end of connector sleeve 290 is received within and securelyattached to the distal end of outer tube 206 and is configured to engagea stain gauge assembly 320 of adapter assembly 200, and a distal end ofconnector sleeve 290 is configured to selectively engage a proximal endof reload 400.

With reference now to FIGS. 52-55, 60 and 69 , adapter assembly 200includes an electrical assembly 310 disposed therewithin, and configuredfor electrical connection with and between handle assembly 100 andreload 400. Electrical assembly 310 serves to allow for calibration andcommunication information (e.g., identifying information, life-cycleinformation, system information, force information) to the maincontroller circuit board 142 b of power-pack core assembly 106 viaelectrical receptacle 149 of power-pack core assembly 106 of handleassembly 100.

Electrical assembly 310 includes a proximal pin connector assembly 312,a proximal harness assembly 314 in the form of a ribbon cable, a distalharness assembly 316 in the form of a ribbon cable, a strain gaugeassembly 320, and a distal electrical connector 322.

Proximal pin connector assembly 312 of electrical assembly 310 issupported within inner housing member 204 and drive coupling assembly210 of knob housing 202. Proximal pin connector assembly 312 includes aplurality of electrical contact blades 312 a supported on a circuitboard 312 b and which enable electrical connection to pass-throughconnector 66 of plate assembly 60 of outer shell housing 10 of handleassembly 100. Proximal harness assembly 314 is electrically connected tocircuit board 312 b of proximal pin connector assembly 312 (FIGS. 53 and54 ).

Strain gauge assembly 320 is electrically connected to proximal pinconnector assembly 312 via proximal and distal harness assemblies 314,316. Strain gauge assembly 320 includes a strain sensor 320 a supportedin outer tube 206 of adapter assembly 200. Strain sensor 320 a iselectrically connected to distal harness assembly 316 via a sensor flexcable 320 b. Strain sensor 320 a defines a lumen therethrough, throughwhich trocar assembly 270 extends.

As illustrated in FIGS. 29-33 , trocar assembly 270 of firstforce/rotation transmitting/converting assembly 240 extends throughstrain sensor 320 a of strain gauge assembly 320. Strain gauge assembly320 provides a closed-loop feedback to a firing/clamping load exhibitedby first, second and third force/rotation transmitting/convertingassembly 240, 250, 260, respectively.

Strain sensor 320 a of strain gauge assembly 320 is supported in outertube 206 and interposed between connector sleeve 290 and support block292. Support block 292 includes a raised ledge 292 b (see FIG. 29 )which extends distally therefrom and which is in contact with strainsensor 320 a.

With reference now to FIGS. 53-55 , electrical assembly 310 includes, asmentioned above, a distal electrical connector 322 which is supported inconnector sleeve 290. Distal electrical connector 322 is configured toselectively mechanically and electrically connect to chip assembly 460of reload 400 when reload 400 is connected to adapter assembly 200.

Distal electrical connector 322 includes a plug member 322 a, first andsecond wires 323 a, 323 b, and first and second contact members 324 a,324 b electrically connected to respective first and second wires 323 a,323 b. Plug member 322 a includes a pair of arms 322 b, 322 c supportingfirst and second contact members 324 a, 324 b, respectively. The pair ofarms 322 b, 322 c are sized and dimensioned to be received within acavity 461 a of chip assembly 460 and about a circuit board assembly 464of reload 400 when reload 400 is connected to adapter assembly 200.

First and second contact members 324 a, 324 b of distal electricalconnector 322 are configured to engage respective contact members 464 bof circuit board assembly 464 of chip assembly 460 of reload 400 whenreload 400 is connected to adapter assembly 200.

With reference now to FIGS. 57-65 , adapter assembly 200 includes arotation assembly 330 configured to enable rotation of adapter assembly200 relative to handle assembly 100. Specifically, outer knob housing202 and an outer tube 206 of adapter assembly 200 are rotatable relativeto drive coupling assembly 210 of adapter assembly 200.

Rotation assembly 330 includes a lock button 332 operably supported onouter knob housing 202. As will be described in further detail below,when rotation assembly 330 is in an unlocked configuration, outer knobhousing 202 and an outer tube 206 are rotatable along a longitudinalaxis of adapter assembly 200 relative to drive coupling assembly 210.When rotation assembly 330 is in a locked configuration, outer knobhousing 202 and an outer tube 206 are rotationally secured relative todrive coupling assembly 210. In particular, being that outer tube 206has a curved profile, rotation of outer knob housing 202 and an outertube 206 about the longitudinal axis of adapter assembly 200 causeshandle assembly 100 to be positioned in various orientations relative toadapter assembly 200 in order to provide the clinician with increasedflexibility in manipulating the surgical instrument in the targetsurgical site.

Lock button 332 of rotation assembly 330 is configured to operativelyengage inner housing member 204 of adapter assembly 200. Inner housingmember 204 is a substantially cylindrical member defining a pair oflongitudinal openings for receiving at least portions of first andsecond force/rotation transmitting/converting assemblies 240, 250therethrough. Inner housing member 204 includes proximal and distalannular flanges 204 a, 204 b and further defines proximal and distalouter annular grooves. The proximal annular groove of inner housingmember 204 accommodates an inner annular flange of outer knob housing202 to rotatably secure outer knob housing 202 to inner housing member204.

With reference still to FIGS. 57-65 , distal annular flange 204 b andthe distal annular groove of inner housing member 204 operate incombination with rotation assembly 330 of adapter assembly 200 to secureouter knob housing 202 in fixed rotational orientations relative toinner housing member 204. In particular, distal annular flange 204 b ofinner housing member 204 defines first, second, and third radial cutouts204 c, 204 d, 204 e configured to selectively receive a lock shoe 334 oflock button 332 of rotation assembly 330. The first and third cutouts204 c, 204 e are opposed to one another, and second cutout 204 d isoriented perpendicular to the first and third cutouts 204 c, 204 e.

With reference to FIGS. 60-61 , outer knob housing 202 has afrustoconical profile including a plurality of ridges configured foroperable engagement by a clinician. Outer knob housing 202 defines aradial opening for operably supporting lock button 332. The opening inouter knob housing 202 is positioned in alignment or registration withthe distal annular groove of inner housing member 204 such that lockbutton 332 of rotation assembly 330 is receivable with the distalannular groove and selectively receivable within each of the first,second, and third cutouts 204 c, 204 d, 204 e in distal annular flange204 b of inner housing member 204.

As mentioned above, rotation assembly 330 of adapter assembly 200includes a lock button 332 operably supported in an opening of outerknob housing 202 and configured for actuating rotation assembly 330.Rotation assembly 330 further includes a lock shoe 334 disposed betweenouter knob housing 202 and inner housing member 204 and axially slidablerelative to lock button 332 and inner housing member 204. A biasingmember 336 is interposed between lock button 332 and lock shoe 334 tourge lock button 332 to a locked position, wherein lock shoe 334 isdisposed within one of first, second, and third cutouts 204 c, 204 d,204 e in distal annular flange 204 b of inner housing member 204.

Lock button 332 is configured for operable engagement by a clinician.Lock button member 332 defines an angled cam slot 332 a formed thereinfor receiving a cam pin or boss 334 a of lock shoe 334. The biasingmember 336 biases lock button 332 and lock shoe 334 away from oneanother, and urges lock shoe 334 into contact with distal annular flange204 b of inner housing member 204 and into one of first, second, andthird cutouts 204 c, 204 d, 204 e in distal annular flange 204 b whenlock shoe 334 is in registration with one of first, second, and thirdcutouts 204 c, 204 d, 204 e.

As mentioned above, lock shoe 334 is configured to be selectivelyreceived within one of the first, second, and third radial cutouts 204c, 204 d, 204 e in distal annular flange 204 b of inner housing member204. Specifically, lock shoe 334 includes or defines a shoulder 334 aprojecting from a surface thereof for receipt in one of the first,second, and third radial cutouts 204 c, 204 d, 204 e in distal annularflange 204 b when shoulder 334 a of lock shoe 334 is in registrationwith one of the first, second, and third radial cutouts 204 c, 204 d,204 e in distal annular flange 204 b and lock button 332 isun-depressed. When shoulder 334 a of lock shoe 334 is free of any of thefirst, second, and third radial cutouts 204 c, 204 d, 204 e in distalannular flange 204 b (e.g., rotation assembly 330 is in an unlockedcondition), outer knob housing 202 is free to rotate relative to innerhousing member 204, and thus adapter assembly 200 is free to rotaterelative to handle assembly 100.

The operation of rotation assembly 330 will now be described withcontinued reference to FIGS. 57-65 . Referring initially to FIGS. 58,59, 61 and 64 , rotation assembly 330 is shown in a locked condition. Inparticular, in the locked condition, shoulder 334 a of lock shoe 334 isreceived within first cutout 204 c in distal annular flange 204 a ofinner housing member 204. Also, in the locked condition, lock button 332of rotation mechanism 330 is biased radially outward by biasing member336.

When lock button 332 of rotation assembly 330 is depressed, as indicatedby arrow “A” in FIG. 64 , lock button 332 moves radially inward againstthe bias of biasing member 336. As lock button 332 moves radiallyinward, lock shoe 334 slides axially in a distal direction, against thebias of biasing member 336. The axial sliding of lock shoe 334 movesshoulder 334 a of lock shoe 334 from within the first radial cutout 204c of the distal annular flange 204 b of inner housing member 204, thusplacing rotation assembly 330 in an unlocked condition and freeing outerknob housing 202 to rotate, as indicated by arrow “B” in FIG. 62 ,relative to inner housing member 204.

Turning now to FIG. 65 , once rotation assembly 330 is in the unlockedcondition, outer knob housing 202 may be rotated relative to innerhousing member 204. The release of lock button 332 allows biasing member336 to bias lock button 332 to its initial position. Similarly, biasingmember 336 biases lock shoe 334 to its initial position. When lock shoe334 is re-aligned with one of the first, second, and third radialcutouts 204 c, 204 d, 204 e of distal annular flange 204 b of innerhousing member 204, as outer knob housing 202 is rotated relative toinner housing member 204, shoulder 334 a of lock shoe 334 is free to bereceived within the respective first, second, and third cutout 204 c,204 d, 204 e and rotationally locks outer knob housing 202 relative toinner housing member 204 and drive coupling assembly 210 of adapterassembly 200.

Rotation assembly 330 may be used throughout the surgical procedure torotate handle assembly 100 and adapter assembly 200 relative to oneanother.

During rotation of outer knob housing 202 relative to inner housingmember 204 and drive coupling assembly 210 of adapter assembly 200,since proximal drive shafts 212, 214, 216 are supported in drivecoupling assembly 210, and since first coupling shaft 251 of secondforce/rotation transmitting/converting assembly 250, second couplingshaft 261 of third force/rotation transmitting/converting assembly 260,and second rotatable proximal drive shaft 281 of first force/rotationtransmitting/converting assembly 240 are supported in inner housingmember 204, the respective angular orientations of proximal drive shaft212 relative to second rotatable proximal drive shaft 281, proximaldrive shaft 216 relative to second coupling shaft 261, and proximaldrive shaft 214 relative to first coupling shaft 251, are changedrelative to one another.

Adapter assembly 200 further includes, as seen in FIGS. 57-59 , anattachment/detachment button 342 supported thereon. Specifically, button342 is supported on drive coupling assembly 210 of adapter assembly 200and is biased by a biasing member 344 to an un-actuated condition.Button 342 includes a lip or ledge 342 a formed therewith that isconfigured to snap behind a corresponding lip or ledge 20 a (FIG. 18 )defined along recess 20 of connecting portion 108 of handle housing 102of handle assembly 100. In use, when adapter assembly 200 is connectedto handle assembly 100, lip 342 a of button 342 is disposed behind lip108 b of connecting portion 108 of handle housing 102 of handle assembly100 to secure and retain adapter assembly 200 and handle assembly 100with one another. In order to permit disconnection of adapter assembly200 and handle assembly 100 from one another, button 342 is depressed oractuated, against the bias of biasing member 344, to disengage lip 342 aof button 342 and lip 108 b of connecting portion 108 of handle housing102 of handle assembly 100.

As illustrated in FIGS. 1 and 66-80 , reload 400 is configured foroperable connection to adapter assembly 200 and is configured to fireand form an annular array of surgical staples, and to sever a ring oftissue.

Reload 400 includes a shipping cap assembly (not shown) that isselectively received on a distal end 402 of reload 400 and can functionto facilitate insertion of reload 400 into a target surgical site and tomaintain staples “S” (FIG. 67 ) within a staple cartridge 420 of reload400. Shipping cap assembly 401 also functions to prevent prematureadvancement of a staple driver assembly 430 (FIG. 66 ) of reload 400 andof a knife assembly 440 (FIG. 66 ) of reload 400 prior to and duringattachment of reload 400 to adapter assembly 200.

With reference now to FIGS. 66-72 , reload 400 includes a housing 410having a proximal end portion 410 a and a distal end portion 410 b, astaple cartridge 420 fixedly secured to distal end portion 410 b ofhousing 410, a staple driver assembly 430 operably received withinhousing 410, a knife assembly 440 operably received within housing 410,a bushing member 450 received within proximal end 410 a of housing 410,and a chip assembly 460 mounted about bushing member 450.

Housing 410 of reload 400 includes an outer cylindrical portion 412 andan inner cylindrical portion 414. A plurality of ribs (not shown)interconnects outer and inner cylindrical portions 412, 414. Outercylindrical portion 412 and inner cylindrical portion 414 of reload 400are coaxial and define a recess 412 a (FIG. 67 ) therebetween configuredto operably receive staple driver assembly 430 and knife assembly 440.Inner cylindrical portion 412 of reload 400 includes a plurality oflongitudinally extending ridges 416 (FIG. 67 ) projecting from an innersurface thereof and configured for radially aligning (e.g., clocking)anvil assembly 510 with reload 400 during a stapling procedure. As willbe described in further detail below, proximal ends 416 a oflongitudinal ridges 416 are configured to facilitate selectivesecurement of shipping cap assembly 401 with reload 400. An annularridge 418 (FIG. 67 ) is formed on an outer surface of inner cylindricalportion 412 and is configured to assist in maintaining knife assembly440 in a retracted position.

Staple cartridge 420 of reload 400 is fixedly secured on distal end 410b of housing 410 and includes a plurality of staple pockets 421 formedtherein which are configured to selectively retain staples “S”.

With continued reference to FIGS. 66-72 , staple driver assembly 430 ofreload 400 includes a driver adapter 432 and a driver 434. A proximalend 432 a of driver adapter 432 is configured for selective contact andabutment with support base 255 d of outer flexible band assembly 255 ofsecond force/rotation transmitting/converting assembly 250 of adapterassembly 200. In operation, during distal advancement of outer flexibleband assembly 255, as described above, support base 255 d of outerflexible band assembly 255 contacts proximal end 432 a of driver adapter432 to advance driver adapter 432 and driver 434 from a first orproximal position to a second or distal position. Driver 434 includes aplurality of driver members 436 aligned with staple pockets 421 ofstaple cartridge 420 for contact with staples “S”. Accordingly,advancement of driver 434 relative to staple cartridge 420 causesejection of the staples “S” from staple cartridge 420.

Still referring to FIGS. 66-72 , knife assembly 440 of reload 400includes a knife carrier 442 and a circular knife 444 secured about adistal end 442 b of knife carrier 442. A proximal end 442 a of knifecarrier 442 is configured for operable connection with support base 265d of inner flexible band assembly 265 of third force/rotationtransmitting/converting assembly 260 of adapter assembly 200. Inoperation, during distal advancement of inner flexible band assembly265, as described above, support base 265 d of inner flexible bandassembly 265 connects with proximal end 442 a of knife carrier 442 toadvance knife carrier 442 and circular knife 444 from a first orproximal position to a second or advanced position to cause the cuttingof tissue disposed between staple cartridge 420 and anvil assembly 510.

Distal end 452 b of bushing member 450 is secured within a proximal end414 a of inner cylindrical portion 414 of housing 410 by a plurality ofridges 452 c formed on distal end 452 b of bushing member 450.

Chip assembly 460 of reload 400 includes a housing 461 from whichannular flange 462 extends. Annular flange 462 extends perpendicular toa longitudinal axis of housing 461. Annular flange 462 is configured tobe received about a distal end 452 b of bushing member 450.

Chip assembly 460 of reload 400 includes a circuit board assembly 464secured within a cavity 461 a of housing 461. Circuit board assembly 464includes a circuit board 464 a, a pair of contact members 464 b and achip 464 c (e.g., storage device 405). A first end of circuit board 464a supports chip 464 c, and a second end of circuit board 464 a supportsfirst and second contact members 464 b. Chip 464 c is awritable/erasable memory chip. Chip 464 c includes the following storedinformation: lot number, staple size, knife diameter, lumen size, firecount, manufacturing stroke offsets, excessive force index, shipping capassembly presence, and demonstration modes. Chip 464 c includes writecapabilities which allow power handle 101 to encode to chip 464 c thatreload 400 has been used to prevent reuse of an empty, spent or firedreload.

In addition to the foregoing, it is contemplated that chip 464 c (e.g.,storage device 405) of chip assembly 460 of reload 400 is configured tobe written to before, during and/or after a surgical procedure withcertain performance data related to the currently performed surgicalprocedure, or to previously performed surgical procedures. Suchperformance data may be written to chip 464 c upon completion of asuccessful firing, or upon an unsuccessful firing of the surgicaldevice, e.g., where the power handle 101 enters a recovery state, asdescribed herein.

Such performance data includes and is not limited to clamping force forthe surgical procedure, stapling force for the surgical procedure,and/or cutting force for the surgical procedure (e.g., maximum clampingforce, stapling force, and/or cutting force). This performance data isalso written to the event log of the memory 141 of the main controller147 of power handle 101, and is recorded in raw data files.

In this manner, in instances where the reload 400 is separated from theadapter 200 and/or power handle 101, and returned to a reprocessingfacility, to the manufacturer or some other facility for disposal,repair, recycling, refurbishing, reprocessing, diagnostic testing or thelike. Accordingly, with the performance data and other aforementionedinformation stored in chip 464 c of reload 400, when the reload 400 isreturned to a facility as part of a field return or the like, theperformance data and other aforementioned information may be downloadedor accessed off of chip 464 c to provide technicians with informationabout the firing conducted with that reload 400 by power handle 101. Thereprocessing facility may include, and is not limited to, a location inthe operating room that is inside the sterile field of the surgery(e.g., in the field of use); and/or a location in the operating roomthat is outside of the sterile field of the surgery, a dedicatedarea/location within the hospital or venue performing the surgery,and/or at a dedicated location outside of the hospital or venueperforming the surgery (e.g., out of the field of use).

The data that is downloaded off of chip 464 c of reload 400 may be usedto diagnose or troubleshoot root causes of performance issues that mayhave occurred in the operative field during use, either with the reload400, the adapter assembly 200, and/or the power handle 101. For example,the data on chip 464 c of reload 400 may be use to assist in identifyingthe particular event log from which a firing in question took place,since the performance data contained on the reload 400 will match theperformance data contained on the power handle 101. The performancedata, and/or other aforementioned information, stored in chip 464 c ofreload 400 may be used to provide information about how the firing ofthat reload 400 was executed by power handle 101, as well as potentialinformation about the conditions of the underlying tissue being operatedon and any other surgical conditions (e.g., environmental conditions,physical/operating conditions of reload 400, adapter assembly 200 and/orpower handle 101, etc.).

For example, with reference to FIG. 82G, and FIGS. 82A-82F (described ingreater detail below), following a successful stapling sequence, asillustrated in FIG. 82D, the procedure enters into a cutting sequence.In accordance with this disclosure, upon a successful cutting sequenceor upon an unsuccessful cutting sequence (where power handle 101 entersinto a recovery state, as described above), the performance data iswritten to chip 464 c of reload 400. More specifically with regard tothe writing of performance data to chip 464 c, as illustrated in FIG.82G, during the cutting sequence (to be described in greater detailbelow), the power handle 101 actuates reload 400 to fire an annularknife 444 of reload 400 (see FIG. 67 ) to cut tissue clamped betweenstaple cartridge 420 of reload 400 and head assembly 512 of anvilassembly 510. When the cutting sequence is stopped, power handle 101automatically writes the performance data to chip 464 c of reload 400,whether the cutting sequence is stop upon either a successful orunsuccessful cutting.

If the cutting was successful, and with the writing of the performancedata to chip 464 c of reload 400 complete, the surgical procedure entersa cut complete state where the head assembly 512 of the anvil assembly510 may be tilted (as described in detail below, and illustrated in FIG.82F). If the cutting was unsuccessful, and with the writing of theperformance data to chip 464 c of reload 400 complete, the surgicalprocedure enters a recover state (e.g., surgical site extraction state)where surgical intervention or the like may be required (as described indetail below, and illustrated in FIG. 82F).

As mentioned throughout, in accordance with the present disclosure,power handle 101 of handle assembly 100 is configured to and capable ofactuating/firing reloads 400 of various sizes (e.g., having staples ofdifferent length depending on a thickness of tissue to be stapled,and/or having knives of different diameter depending on the diameter oftissue to be anastomosed). In order to be able to fire various reloads400 each potentially loaded with staples of different lengths, the maincontroller 147 of power handle 101 is configured and programmed tomonitor and record the axial position of outer flexible band assembly255 and inner flexible band assembly 265 of adapter assembly 200, suchthat certain lengths of actuation of reloads 400 can be achieved andmonitored to ensure proper formation and firing of the particularlysized staples loaded therein, and ensure proper advancement of annularknife 444 to completely cut the tissue drawn within the reload 400 andcomplete the anastomosis.

In accordance with the present disclosure, since the main controller 147of power handle 101 monitors the axial position of outer flexible bandassembly 255 and inner flexible band assembly 265, a minimum and amaximum length of actuation for each particular reload 400 connected topower handle 101 can be set based on information stored on chip 464 c ofreload 400 (e.g., staple size, knife diameter, lumen size, minimum cutstroke length, maximum cut stroke length, etc.). For example, theminimum and maximum length of actuation of inner flexible band assembly265 for a reload 400 having relatively shorter staples will be differentthan the minimum and maximum length of actuation of inner flexible bandassembly 265 for a reload 400 having relatively longer staples. In thismanner, the minimum and maximum cut stroke for the annular knife 444 canbe set for the particular reload 400 attached. For example, for reloads400 having relatively shorter staples, the minimum and maximum cutstroke for the respective annular knife 444 can be different than theminimum and maximum cut stroke for the respective annular knife 444 ofreloads 400 having relatively longer staples.

Further, in accordance with the present disclosure, by monitoring amaximum cut stroke for the inner band assembly 265 (associated with aparticular reload 400), excessive cut band actuation and/or tissuecompression may be avoided. Specifically, a maximum cut stroke for theinner band assembly 265 may be set by the main controller 147 of powerhandle 101 depending on the particular reload 400 connected to the powerhandle 101 (via adapter assembly 200). Thereafter, the main controller147 monitors and records the axial position of the inner band assembly265 to confirm that the maximum cut stroke (previously set) is notexceeded.

As mentioned above, and in accordance with the present disclosure, avalue for the minimum and the maximum cut stroke can be specific to eachparticular reload 400 (e.g., based on staple size, knife diameter,etc.), and the value for the minimum and the maximum cut stroke can bechanged for each firing of power handle 101 based on information storedon chip 464 c of reload 400 and/or based on information stored in orcommunicated to the power handle 101.

Turning back to FIGS. 66-72 , proximal end 410 a of housing 410 isconfigured for selective connection to connector sleeve 290 of adapterassembly 200. Specifically, outer cylindrical portion 412 of housing 410terminates in a proximal cylindrical flange 412 a having an innerdiameter which is larger than a diameter of a distal end portion 290 aof connector sleeve 290 of adapter assembly 200. Further, proximal end432 a of driver adapter 432 has an outer diameter which is smaller thanthe diameter of distal end portion 290 a of connector sleeve 290.

Reload 400 includes a compressible release ring 413 supported on flange412 a of outer cylindrical portion 412 of housing 410. Release ring 413has a substantially ovoid profile including a relative long axis and arelative short axis. In operation, when radially inward directed forcesact along the long axis of release ring 413 (as indicated by arrows “A1”of FIG. 70 ), release ring 413 flexes radially outwardly along the shortaxis thereof (as indicated by arrows “A2” of FIG. 70 ).

Release ring 413 includes a ramp feature 413 a projecting radiallyinwardly and located substantially along the short axis of release ring413. Ramp feature 413 a of release ring 413 extends through a window 412b defined in flange 412 a of outer cylindrical portion 412 of housing410. Ramp feature 413 a of release ring 413 projects sufficientlyradially inwardly so as to be selectively received in a window 290 bdefined in distal end portion 290 a of connector sleeve 290.

Reload 400 includes a retaining ring 415 connected to outer cylindricalportion 412 of housing 410 and configured to help retain release ring413 on outer cylindrical portion 412 of housing 410.

For radial alignment and clocking of reload 400 with adapter assembly200, reload 400 includes a longitudinally extending rib 412 c projectingradially inwardly from outer cylindrical portion 412 of housing 410which is configured for slidable receipt in a longitudinally extendingslot 290 c defined in distal end portion 290 a of connector sleeve 290.

To connect reload 400 with adapter assembly 200, rib 412 c of reload 400is radially aligned with longitudinally extending slot 290 c ofconnector sleeve 290 of adapter assembly 200, reload 400 and adapterassembly 200 are then axially approximated towards one another untildistal end portion 290 a of connector sleeve 290 is received withinflange 412 a of outer cylindrical portion 412 of housing 410 and untilramp feature 413 a of release ring 413 is received in window 290 b ofconnector sleeve 290, reload 400 and adapter assembly 200 are thuslocked together.

When reload 400 is connected with adapter assembly 200, distalelectrical connector 322 of adapter assembly 200 is mechanically andelectrically connected to chip assembly 460 of reload 400.

To disconnect reload 400 and adapter assembly 200 from one another,release ring 413 is squeezed along the long axis thereof (in thedirection of arrows “A1”) to thereby remove ramp feature 413 a ofrelease ring 413 from within window 290 b of connector sleeve 290, andthus allowing reload 400 and adapter assembly 200 to be axiallyseparated from one another.

Referring now to FIGS. 71-75 , an anvil assembly 510 is provided and isconfigured for selective connection to trocar member 274 of adapterassembly 200 and for cooperation with reload 400.

Anvil assembly 510 includes a head assembly 512 and a center rodassembly 514. Head assembly 512 includes a post 516, a housing 518, acutting ring 522, a cutting ring cover 523, an anvil plate 524, a spaceror washer 525, a cam latch member 526, and a retainer member 527. Post516 is centrally positioned within housing 518.

With reference still to FIGS. 73-75 , anvil plate 524 is supported in anouter annular recess 528 of housing 518 and includes a plurality ofstaple pockets 530 formed therein and configured to receive and formstaples.

Cutting ring 522 includes a central opening which is positioned aboutpost 516 within an inner annular recess of housing 518 between post 516and outer annular recess 528. Cutting ring 522 is formed frompolyethylene. Cutting ring cover 523 is secured to an outwardly facingor proximal surface of cutting ring 522.

Retainer member 527 is positioned in the inner annular recess betweencutting ring 522 and a back wall of housing 518. Retainer member 527 isannular and includes a plurality of deformable tabs which engage a rearsurface of cutting ring 522. Retainer member 527 prevents cutting ring522 from moving or being pushed into the inner annular recess of housing518 until a predetermined force sufficient to deform the tabs has beenapplied to cutting ring 522. When the predetermined force is reached,e.g., during cutting of tissue, cutting ring 522 is urged into the innerannular recess 536 and compresses the retainer members.

Turning back to FIG. 75 , anvil center rod assembly 514 includes acenter rod 552, a plunger 554 and a plunger spring 556. A first end ofcenter rod 552 includes a pair of arms 159 which define a cavity 159 a.A pivot member 562 is provided to pivotally secure post 516 to centerrod 552 such that anvil head assembly 512 is pivotally mounted to anvilcenter rod assembly 514.

Cam latch member 526 is pivotally mounted within a transverse slot ofpost 516 of housing 518 and about pivot member 562. Cam latch member 526has an outer cam profile which permits plunger 554 to move forward ascam latch member 526 rotates in a clockwise direction, and permitsplunger 554 to be retracted as cam latch member rotates in acounter-clockwise direction.

Plunger 554 is slidably positioned in a bore formed in the first end ofcenter rod 552. Plunger 554 includes an engagement finger which isoffset from the pivot axis of anvil head assembly 512 and biased intoengagement with an edge of cam latch 526. Engagement of the finger ofplunger 554 with the edge of cam latch 526 presses a leading portion ofthe edge of cam latch 526 against an inner periphery of cutting ring 522to urge anvil head assembly 512 to an operative or non-tilted positionon center rod 552.

Anvil head assembly 512 may be tilted relative to anvil center rodassembly 514 in a pre-fired tilted position. Tilting of anvil headassembly 512 relative to anvil center rod assembly 514 causes the bodyportion of cam latch member 526 to engage a finger 166 of plunger 554.As cam latch member 526 rotates with the tilting of anvil head assembly512, plunger 554 is retracted with the bore of anvil center rod assembly514, thereby compressing spring 556. In this manner, finger 566 ofplunger 554 is distally biased against the body portion of cam latchmember 526.

With reference to FIGS. 74-75 , a second end of center rod 552 includesa bore 580 defined by a plurality of flexible arms 582. The proximal endof each of the flexible arms 582 includes an internal shoulderdimensioned to releasably engage a shoulder of trocar 274 of trocarassembly 270 of adapter assembly 200 to secure anvil assembly 510 toadapter assembly 200. A plurality of splines 586 are formed about centerrod 552. Splines 586 function to align and/or clock anvil assembly 510with staple cartridge 420 of reload 400.

With reference now to FIGS. 76-81 , reload 400 is configured toselective optional connection with an external irrigation source via anirrigation tube 590. Irrigation tube 590 is configured to deliver air orsaline to the anastomosis site for the purpose of leak testing, forimproved insertion or for insufflating the rectal stump.

Irrigation tube 590 terminates at a proximal end 590 a thereof with aproximal luer fitting 591 configured to connect to a syringe (notshown), and at a distal end 590 b with a distal fitting 592 configuredto selectively snap-fit connect to a port 410 c of housing 410 of reload400. Distal fitting 592 includes a pair of resilient fingers 592 aconfigured to engage respective shoulders 410 d defined in port 410 c ofhousing 410.

With reference to FIG. 89 , a schematic diagram of the power handle 101,the circular adapter assembly 200, and the reload 400, is shown. Forbrevity, only one of the motors 152, 154, 156 is shown, namely, motor152. The motor 152 is coupled to the battery 144. In embodiments, themotor 152 may be coupled to any suitable power source configured toprovide electrical energy to the motor 152, such as an AC/DCtransformer.

The battery 144 and the motor 152 are coupled to the motor controllercircuit board 142 a having a motor controller 143 which controls theoperation of the motor 152 including the flow of electrical energy fromthe battery 144 to the motor 152. The main controller circuit board 142b (FIGS. 12 and 13 ) includes a main controller 147, which controls thepower handle 101. The motor controller 143 includes a plurality ofsensors 408 a, 408 b, 408 n configured to measure operational states ofthe motor 152 and the battery 144. The sensors 408 a-n may includevoltage sensors, current sensors, temperature sensors, telemetrysensors, optical sensors, and combinations thereof. The sensors 408a-408 n may measure voltage, current, and other electrical properties ofthe electrical energy supplied by the battery 144. The sensors 408 a-408n may also measure angular velocity (e.g., rotational speed) asrevolutions per minute (RPM), torque, temperature, current draw, andother operational properties of the motor 152. Angular velocity may bedetermined by measuring the rotation of the motor 152 or a drive shaft(not shown) coupled thereto and rotatable by the motor 152. Position ofvarious axially movable drive shafts may also be determined by usingvarious linear sensors disposed in or in proximity to the shafts orextrapolated from the RPM measurements. In embodiments, torque may becalculated based on the regulated current draw of the motor 152 at aconstant RPM. In further embodiments, the motor controller 143 and/orthe main controller 147 may measure time and process the above-describedvalues as a function of time, including integration and/ordifferentiation, e.g., to determine the rate of change in the measuredvalues. The main controller 147 is also configured to determine distancetraveled of various components of the circular adapter assembly 200and/or the reload 400 by counting revolutions of the motors 152, 154,and 156.

The motor controller 143 is coupled to the main controller 147, whichincludes a plurality of inputs and outputs for interfacing with themotor controller 143. In particular, the main controller 147 receivesmeasured sensor signals from the motor controller 143 regardingoperational status of the motor 152 and the battery 144 and, in turn,outputs control signals to the motor controller 143 to control theoperation of the motor 152 based on the sensor readings and specificalgorithm instructions, which are discussed in more detail below. Themain controller 147 is also configured to accept a plurality of userinputs from a user interface (e.g., switches, buttons, touch screen,etc. coupled to the main controller 147).

The main controller 147 is also coupled to a memory 141 that is disposedon the main controller circuit board 142 b. The memory 141 may includevolatile (e.g., RAM) and non-volatile storage configured to store data,including software instructions for operating the power handle 101. Themain controller 147 is also coupled to the strain gauge 320 of thecircular adapter assembly 200 using a wired or a wireless connection andis configured to receive strain measurements from the strain gauge 320which are used during operation of the power handle 101.

The reload 400 includes a data/information storage device 405 (e.g.,chip 464 c). The circular adapter assembly 200 also includes a storagedevice 407. The storage devices 405 and 407 include non-volatile storagemedium (e.g., EEPROM) that is configured to store any data pertaining tothe reload 400 and the circular adapter assembly 200, respectively,including but not limited to, usage count, identification information,model number, serial number, staple size, knife diameter, stroke length,maximum actuation force, minimum actuation force, factory calibrationdata, and the like. In embodiments, the data may be encrypted and isonly decryptable by devices (e.g., main controller 147) that haveappropriate keys. The data may also be used by the main controller 147to authenticate the circular adapter assembly 200 and/or the reload 400.The storage devices 405 and 407 may be configured in read only orread/write modes, allowing the main controller 147 to read as well aswrite data onto the storage device 405 and 407.

Operation of the handle assembly 100, the circular adapter assembly 200,and the reload 400 is described below with reference to FIGS. 82A-F,which shows a flow chart of the operation process. With particularreference to FIG. 82A, the power handle 101 is removed from a charger(not shown) and is activated. The power handle 101 performs a self-checkupon activation and if the self-check passes, the power handle 101displays an animation on the display screen 146 illustrating how thepower handle 101 should be inserted into shell housing 10.

After the power handle 101 is inserted into the shell housing 10, thepower handle 101 verifies that it is properly inserted into the shellhousing 10 by establishing communications with the electrical connector66 of the shell housing 10, which has a chip (not shown) disposedtherein. The chip within the electrical connector 66 stores a usagecounter which the power handle 101 uses to confirm that the shellhousing 10 has not been previously used. The data (e.g., usage count)stored on the chip is encrypted and is authenticated by the power handle101 prior to determining whether the usage count stored on the chipexceeds the threshold (e.g., if the shell housing 10 has been previouslyused).

With reference to FIG. 82B, after the power handle 101 is enclosedwithin the shell housing 10 to form handle assembly 100, adapterassembly 200 is coupled to handle assembly 100. After attachment ofcircular adapter assembly 200, handle assembly 100 initially verifiesthat circular adapter assembly 200 is coupled thereto by establishingcommunications with the storage device 407 of the circular adapterassembly 200 and authenticates circular adapter assembly 200. The data(e.g., usage count) stored on the storage device 407 is encrypted and isauthenticated by the power handle 101 prior to determining whether theusage count stored on the storage device 407 exceeds the threshold(e.g., if the adapter assembly 200 has been previously used). Powerhandle 101 then performs verification checks (e.g., end of life checks,trocar member 274 missing, etc.) and calibrates circular adapterassembly 200 after the handle assembly 100 confirms that the trocarmember 274 is attached.

After circular adapter assembly 200 is calibrated, an unused reload 400,with the shipping cap assembly 401, is coupled to circular adapterassembly 200. The handle assembly 100 verifies that circular reload 400is attached to circular adapter assembly 200 by establishingcommunications with the storage device 405 of circular reload 400. Withreference to FIG. 82C, power handle 101 also authenticates the storagedevice 405 and confirms that circular reload 400 has not been previouslyfired by checking the usage count. The usage count is adjusted andencoded by handle assembly 100 after use of circular reload 400. Ifcircular reload 400 has been previously used, handle assembly 100displays an error indicating the same on the display screen 146.

The power handle 101 also performs calibration with the reload 400attached to the circular adapter assembly 200 to determine a startinghard stop position. The main controller 147 calculates the distancetravelled by the motors 152, 154, 156 to determine the hard stop. Themain controller 147 also utilizes the traveled distance duringcalibration to confirm that the reload 400 is unused. Thus, if thetraveled distance is determined to be above a predetermined hard stopthreshold, then the main controller 147 confirms that the staples werepreviously ejected from the reload 400 and marks the reload 400 as used,if the reload 400 was not properly marked before. Once the anvilassembly 510 is attached, the main controller 147 performs anothercalibration.

With continued reference to FIG. 82C, upon attaching circular reload 400and confirming that circular reload 400 is unused and has beenauthenticated, handle assembly 100 prompts the user to eject theshipping cap assembly 401 by prompting the user to press up on thetoggle control button 30. The prompt is displayed as an animation on thedisplay screen 146 with a flashing arrow pointing toward the togglecontrol button 30. The user depresses the upper portion of the togglecontrol button 30, which activates an automatic extension (andretraction) of trocar member 274 until the shipping cap assembly 401 isejected, at which point the shipping cap ejection process is completeand the handle assembly 100 is now ready for use.

In embodiments, the circular adapter assembly 200 also operates withreloads 400 having disposable trans-anal/abdominal introducers. Once thereload 400 with the introducer is attached, handle assembly 100 shows aready screen. This allows the user to insert circular adapter assembly200 along with the reload 400 more easily through intra-abdominalincisions. Thus, when the toggle control button 30 is pressed, a promptfor ejecting the introducer is displayed, which is similar to theanimation for ejecting the shipping cap assembly 401. The user depressesthe upper portion of the toggle control button 30, which activates anautomatic extension (and retraction) of the trocar member 274 until theintroducer is ejected, at which point the introducer ejection process iscomplete.

With continued reference to FIG. 82C, after the shipping cap assembly401 or the introducer is removed, the user commences a surgicalprocedure which includes preparing the target tissue area andpositioning circular adapter assembly 200 within the colorectal or uppergastrointestinal region or until trocar member 274 extends sufficientlyto permit piercing of tissue. The user presses the toggle control button30 to extend the trocar member 274 until it pierces tissue. While thetrocar member 274 is extending, an animation illustrating the extensionprocess is displayed on the display screen 146. In addition, distancetraveled by the trocar member 274 is shown as a scale and the directionof the movement of the trocar member 274 is shown via an arrow. Thetrocar member 274 is extended until it reaches the maximum extensiondistance which is indicated on the display screen 146.

With reference to FIGS. 82C-D and 86, which shows a flow chart of theclamping process, after extension of the trocar member 274, the anvilassembly 510 (already positioned by surgeon) is attached to the trocarmember 274 and the user begins the clamping process on the tissueinterposed between circular reload 400 and the anvil assembly 510 bypressing on the bottom of the toggle control button 30. The clampingprocess is also shown as an animation on the display screen 146, but asa reverse of the animation of the extension of the trocar member 274,e.g., an arrow is highlighted illustrating the retraction direction.

During clamping, the anvil assembly 510 is retracted toward the circularreload 400 until reaching a fully compressed position, namely positionof the anvil assembly 510 at which the tissue is fully compressedbetween the anvil assembly 510 and the reload 400. Fully compresseddistance varies for each of the different types of reloads (e.g., thedistance is about 29 mm for 25 mm reloads). While clamping, the straingauge assembly 320 continuously provides measurements to the maincontroller on the force imparted on the first rotation transmittingassembly 240 as it moves the anvil assembly 510.

With reference to FIG. 83 , which schematically illustrates the traveldistance and speed of the anvil assembly 510 as it is retracted by thefirst motor 152, the anvil assembly 510 is initially retracted from afull open position marker 600 at a first speed for a first segment fromthe full open position marker 600 to a first distance marker 602.Thereafter, the anvil assembly 510 traverses a second distance from thefirst distance marker 602 to a second distance marker 604 at the secondspeed, which is slower than the first speed. As the anvil assembly 510is traversing the second segment, the main controller 147 continuouslyverifies whether the measured force is within predefined parameters todetermine if the measured force exceeds a high force threshold limitprior to reaching a starting compression distance (FIGS. 83 and 86 ).This measurement is used to detect misalignment of the splines 586 oftrocar member 274 with longitudinally extending ridges 416 of the reload400. If the force is higher than the high force threshold, then thepower handle 101 temporarily reverses the rotation transmitting assembly240 to retract the anvil assembly in an attempt to correct themisalignment of the splines 586. The main controller 147 then reattemptsto continue clamping until a third distance marker 604 is reached. Ifthe third distance marker 604 is not reached within a predeterminedperiod of time, the main controller 147 then issues an error, includingan alarm on the display screen 146 prompting the user to inspect theanvil assembly 510. After inspection and clearance of any obstruction,the user may then restart the clamping process.

Once the anvil assembly 510 reaches the third distance marker 604 at theend of the second segment, the power handle 101 performs a rotationverification to check position of the anvil assembly 510. Then the maincontroller commences a controlled tissue compression (“CTC”) algorithmwhich varies the clamping speed during tissue compression withoutexceeding a target compression force.

The CTC accounts for slow-changing and rapid-changing forces imparted onthe tissue during compression with a second-order predictive forcefilter. As the predicted force approaches the target force, the clampingspeed is slowed to prevent over-shoot. When the measured force reachesthe target force and the clamp gap has not yet been achieved, clampingis stopped to allow for tissue relaxation. During tissue relaxation,after the measured force falls below the target clamping force, the CTCrecommences. The force exerted on tissue is derived from the strainmeasurements by the main controller 147 from the strain gauge assembly320.

During CTC, the user continues to press down on the toggle controlbutton 30 to continue operation of handle assembly 100. The thirddistance marker 604, at which the controller commences the CTC,corresponds to the distance at which the anvil assembly 510 begins tocompress the tissue against the staple guide of the circular reload 400for the remainder of the clamping process. CTC controls the movement ofthe anvil assembly 510 during a third segment, from the third distancemarker 604 to a fourth distance marker 606, which corresponds to thefully compressed position of the anvil assembly 510. CTC continues untilthe anvil assembly 510 reaches the fourth distance marker 606. Duringclamping, if no forces are detected, the handle assembly 100 identifiesthat the anvil assembly 510 is missing and the handle assembly 100issues an error.

The CTC is run for a predetermined time period, namely, a first timeperiod, and an optional second time period. During execution of the CTC,the main controller monitors force based on strain as measured by thestrain gauge assembly 320 that is imparted on the first rotationtransmitting assembly 240 as it moves the anvil assembly 510 until themeasured force approaches the target clamping force.

During execution of the CTC, the main controller 147 determines whetherthe measured forces approaches the target clamping force by calculatinga predicted clamping force using a second-order predictive filter.Target clamping force may be any suitable threshold from about 100pounds to about 200 pounds, in embodiments, the target clamping forcemay be approximately 150 pounds. The CTC calculates a predicted clampingforce and compares it to the target clamping force. The main controllersamples a plurality of strain gauge values at predetermined frequency(e.g., every 1 millisecond) during a predetermined sampling time period.The main controller 147 then uses a first plurality of strain gaugesamples obtained during the sampling time period to calculate a filteredstrain gauge value. The main controller 147 stores a plurality offiltered strain gauge values and uses three strain gauge samples topredict the target clamping force. In particular, the main controller147 initially calculates a first difference between the first two (e.g.,first and second) filtered strain gauge values, which provides afirst-order comparison. More specifically, the main controller 147 thencalculates a second difference between subsequent two filtered straingauge values (e.g., second and third values). In embodiments, thesubsequent filtered strain gauge values may be any other subsequentvalues, rather than encompassing the second value used to calculate thefirst difference. The first difference is then divided by the seconddifference, to obtain a percentage of the difference. The maincontroller determines the target clamping force based on a predictedstrain change, which is calculated by multiplying the first differenceby the percentage of the difference and a value representing futureperiods of strain extrapolation. The predicted strain change is thenadded to the current filtered strain gauge value to determine apredicted strain value, which corresponds to the predicted clampingforce.

If the predicted clamping force is above the target force, the PWMvoltage driving the motor 152, which is driving the first rotationtransmitting assembly 240 is set to zero. The force is continued to bemonitored, and once the force drops below a target threshold, the speedof the motor 152 is set to an updated speed to continue the clampingprocess. This process repeats until the fourth distance marker 606 isreached.

The target speed is calculated by the main controller 147 based on astrain ratio. The strain ratio is calculated by subtracting thepredicated strain value from the target clamping force and dividing thedifference by the target clamping force. The strain ratio is then usedto determine a speed offset by multiplying a difference between maximumand minimum speeds of the motor 152 by the strain ratio. The speedoffset is then added to the minimum speed of the motor 152 to determinethe target speed. The target speed is used to control the motor 152 inresponse to the motor deviating by a predetermined amount from currentlyset speed (e.g., if the motor 152 deviates by about 50 revolutions perminute). In addition, the motor 152 is set to a newly calculated targetspeed, if the current speed of the motor 152 is zero, e.g., followingthe predicted clamping force approaching the target force. This allowsfor varying the speed of the motor 152 while maintaining the desiredforce on the tissue during clamping.

The target clamping force is fixed for the first time period. When thicktissue is encountered, the clamp gap may not be attained within thefirst time period (e.g., reaching the fourth distance marker 606),clamping is stopped, and the operator is notified via the displayscreen. If the operator chooses to continue the clamping operation, CTCcontinues to operate for the second time period, during which the targetclamping force is incremented until the maximum force is reached. Duringthe second period, clamping movement distance is monitored to determineif the anvil assembly 510 is moved in response to incremental forceincreases. Thereafter, the clamp distance is periodically monitored forany minimal movement. If no minimal movement is detected, the targetforce is dynamically incremented by a proportional amount based on adifference between the current clamp position and the fourth distancemarker 606. If a maximum force, which is higher than the target clampingforce, is detected, all clamping is stopped. In addition, if clamping isnot achieved within the second time period, then the CTC issues analarm. This may include instructing the user on the display screen 146to check the clamp site for obstructions. If none are found, the usermay continue the clamping process. If the clamping is not complete,e.g., second time period expires and/or the maximum force limit isreached, another alarm is triggered, instructing the user to checktissue thickness and to use a larger reload 400 to restart the clampingprocess.

With reference to FIGS. 82C-D and 86, once CTC is commenced, the displayscreen 146 displays a CTC user interface after the main controller 147confirms that the anvil assembly 510 is present based on detection of aminimum force. In particular, the distance scale on the display screen146 is replaced with a gauge illustrating the force being imparted onthe tissue, and the trocar is replaced with the anvil and tissue beingcompressed. Also displayed is the progress of the clamping until thefourth distance marker 606 is reached. Thus, as the anvil assembly 510is being moved to compress the tissue under the CTC, the gauge, theanvil animation, and the distance traveled by the anvil assembly 510 areupdated continuously to provide real time feedback regarding the CTCprogress.

During CTC, the strain gauge assembly 320 continuously providesmeasurements to the main controller on the force imparted on the firstrotation transmitting assembly 240 as it moves the anvil assembly 510.The force measured by the strain gauge assembly 320 is represented bythe gauge on the display screen 146, which is separated into threezones, zone 1 shows the force from 0% to 50% of the target clamp force,zone 2 shows the force from 51% to 100%, and zone 3 shows the maximumforce above the target clamp force. High force caution graphic isdisplayed on screen for zone 3, the user is required to perform a secondactivation of the toggle to confirm clamping despite zone 3 high forces.

The user can then press the toggle control button 30 to re-clamp, whichwould move the anvil assembly 510 until the force reaches the maximumforce limit of zone 3. This allows for further compression of the tissuein certain circumstances where the user deems it necessary, e.g., basedon tissue thickness. Once the CTC algorithm is complete and tissue iscompressed, handle assembly 100 activates an LED and issues a toneindicating the same and the CTC screen indicating 100% compression iscontinuously displayed on the display screen 146 until the staplingsequence is started. A pre-fire calibration is performed prior tocommencement of the stapling sequence.

With reference to FIGS. 82D and 87A-B, to initiate stapling sequence,the user presses one of the safety buttons 36 a or 36 b of the powerhandle 101, which acts as a safety and arms the toggle control button30, allowing it to commence stapling. Upon activation of the safetybutton 36 a or 36 b, a second rotation verification calibration check isperformed. The display screen 146 transitions to the stapling sequencedisplay, which includes a circle illustrating an animated view of acircular anastomosis, a progress bar, and a staple icon. The staplingsequence screen is displayed until user initiates the stapling sequence,exits the stapling sequence, or unclamps. At the start of the staplingsequence, the LED begins to flash and an audio tone is played. The LEDcontinues to flash throughout the duration of the stapling and cuttingsequences.

To commence the stapling sequence, the user presses down on the togglecontrol button 30, which moves the second rotation transmitting assembly250 to convert rotation to linear motion and to eject and form staplesfrom circular reload 400. In particular, during the firing sequence, thesecond motor 152 advances the driver 434 using the second rotationtransmitting assembly 250. The force imparted on the second rotationtransmitting assembly 250 is monitored by the strain gauge assembly 320.The process is deemed complete once the second rotation transmittingassembly 250 reaches a hard stop corresponding to a force threshold anddetected by the strain gauge assembly 320. This indicates that thestaples have been successfully ejected and deformed against the anvilassembly 510.

With reference to FIG. 84 , which schematically illustrates the traveldistance and speed of the second motor 154 as it advances the driver434, driver 434 is initially advanced from a first position marker 608(e.g., hardstop) at a first speed for a first segment from the firstdistance marker 608 to a second distance marker 610. From the seconddistance marker 610, the driver 434 is advanced at a second speed,slower than the first speed, until it reaches a third distance marker612, to eject the staples.

During the first segment, the second motor 154 advances the driver 434until the driver 434 contacts the staples to commence firing. The maincontroller 147 also writes to the storage devices 405 and 407 of thereload 400 and the circular adapter assembly 200. In particular, maincontroller 147 marks the reload 400 as “used” in the storage device 405and increments the usage count in the storage device 407 of the circularadapter assembly 200.

After reaching the second distance marker 610, the second motor 154 isoperated at the second, slower speed to eject the staples from thereload 400. With reference to FIG. 87B, during the second segment, asthe staples are ejected from the reload 400 to staple tissue, the maincontroller 147 continually monitors the strain measured by the straingauge assembly 320 and determines whether the force corresponding to themeasured strain is between a minimum stapling force and a maximumstapling force. The stapling force range may be stored in the storagedevice 405 of the reload 400 and used by the main controller 147 duringthe stapling sequence. Determination whether the measured force is belowthe minimum stapling force is used to verify that the staples arepresent in the reload 400. In addition, a low force may be alsoindicative of a failure of the strain gauge 320. If the measured forceis below the minimum stapling force, then the main controller 147signals the second motor 154 to retract the driver 434 to the seconddistance marker 610. The main controller 147 also displays a sequence onthe display 146 instructing the user the steps to exit stapling sequenceand retract the anvil assembly 510. After removing the anvil assembly510, the user may replace the circular adapter assembly 200 and thereload 400 and restart the stapling process.

If the measured force is above the maximum stapling force, which may beabout 500 lbs., the main controller 147 stops the second motor 154 anddisplays a sequence on the display 146 instructing the user the steps toexit the stapling sequence. However, the user may still continue thestapling process without force limit detection by pressing on togglecontrol button 30.

The main controller 147 determines that the stapling process iscompleted successfully, if the second motor 154 reached a third distancemarker 612 associated with stapled tissue and during this movement themeasured strain was within the minimum and maximum stapling forcelimits. Thereafter, the second motor 154 retracts the driver 434 to afourth distance marker 614 to release pressure on the tissue andsubsequently to the second distance marker 610 prior to starting thecutting sequence.

The main controller 147 is also configured to account for bandcompression of outer flexible band assembly 255 during the staplingprocess which may result in a non-linear relationship between motorposition as determined by the main controller 147 and position ofcomponents of the circular adapter assembly 200. The main controller 147is configured to resolve the discrepancy between the calculated positionof the motors 152, 154, 156 and the actual position of the components ofthe circular adapter assembly 200 using a second order mapping of forcechanges that result in the discrepancies. The force changes are based onthe strain measurements from the strain gauge assembly 320. Inparticular, the main controller 147 maintains a count of lost turns bythe motors 152, 154, 156, namely, turns that did not result in movementof the components of the circular adapter assembly 200, e.g., due tocompression, based on the force imparted on the components of thecircular adapter assembly 200. The main controller 147 accumulates thetotal lost turns each time the imparted force changes by a predeterminedamount, e.g., about 5 lbs. The motor position is then adjusted by thetotal accumulated lost-turns value to determine whether the targetposition has been attained.

With reference to FIG. 82D, progress of staple firing is illustrated byan animation of the anastomosis, the firing progress bar, and stapleformation. In particular, the animation illustrates staple legspenetrating tissue and then forming to create concentric staple lines.Once the stapling sequence is complete, the outer circumference isdisplayed in green. The staple icon also shows initially unformedstaples, and then shows the legs of the staples being curled inward. Theprogress bar is separated into two segments, the first segment beingindicative of the stapling process and the second segment beingindicative of the cutting process. Thus, as the stapling sequence isongoing the progress bar continues to fill until it reaches itsmidpoint.

With reference to FIGS. 82E and 88A-B, after the stapling sequence iscomplete, the power handle 101 automatically commences the cuttingsequence. During the cutting sequence, the third motor 154 advances theknife assembly 440 using the third rotation transmitting assembly 260.The force imparted on the third rotation transmitting assembly 260 ismonitored by the strain gauge assembly 320. The process is deemedcomplete once the third rotation transmitting assembly 260 reaches ahard stop corresponding to a force threshold and detected by the straingauge assembly 320 or a maximum position is reached. This indicates thatthe knife assembly 320 has cut through the stapled tissue.

With reference to FIG. 85 , which schematically illustrates the traveldistance and speed of the third motor 156 as it advances the knifeassembly 440. The knife assembly 440 is initially advanced from a firstposition marker 616 at a first speed for a first segment from the firstdistance marker 616 until a second distance marker 618. From the seconddistance marker 618, the knife assembly 440 is advanced at a secondspeed, slower than the first speed, until it reaches a third distancemarker 620, to cut the stapled tissue.

During the first segment, the third motor 156 advances the knifeassembly 440 until the knife assembly 440 contacts the stapled tissue.After reaching the second distance marker 618, the third motor 154 isoperated at the second, slower speed to cut the stapled tissue. Withreference to FIGS. 88A-B, during the second segment, as the knifeassembly 440 is advanced to cut tissue, the main controller 147continually monitors the strain measured by the strain gauge assembly320 and determines whether the force corresponding to the measuredstrain is between a target cutting force and a maximum cutting force.The target cutting force and the maximum cutting force may be stored inthe storage device 405 of the reload 400 and used by the main controller147 during cutting sequence. If the target cutting force is not reachedduring the cutting sequence, which is indicative of improper cutting,then the main controller 147 signals the third motor 156 retract theknife assembly 440 allowing the user to open the reload 400 and abortthe cutting sequence. The main controller 147 also displays a sequenceon the display 146 indicating to the user the steps to exit the cuttingsequence and retract the anvil assembly 510. After removing the anvilassembly 510, the user may replace the circular adapter assembly 200 andthe reload 400 and restart the stapling process. If the measured forceis above the maximum cutting force, the main controller 147 stops thethird motor 156 and displays a sequence on the display 146 instructingthe user to exit the cutting sequence.

The main controller 147 determines that the stapling process iscompleted successfully, if the knife assembly 440 being moved by thethird motor 156 reached a third distance marker 620 associated with cuttissue and during this movement the measured strain was within thetarget and maximum cutting force limits. Thereafter, the third motor 154retracts the knife assembly 440 back to the first distance marker 616.

Each of the distance markers 600-620 are stored in the memory 141 and/orthe storage device 405 and are used by the main controller 147 tocontrol the operation of the power handle 101 to actuate variouscomponents of the circular adapter assembly 200 based thereon. As notedabove the distance markers 600-620 may be different for different typeof reloads accounting for variations in staple size, diameter of thereload, etc. In addition, the distance markers 600-620 are set from thehard stop as determined during the calibration process described above.

With reference to FIG. 82E, the cutting sequence is illustrated by thesame user interface, except the staple icon is grayed out and a knifeicon is highlighted. During the cutting sequence, the knife icon isanimated with motion and the progress bar moves from its midpoint to theright. In addition, the inner circumference of the circle is displayedin green once the cutting sequence is complete. During the cuttingsequence, the force imparted on the third rotation transmitting assembly260 is monitored by the strain gauge assembly 320 to ensure that maximumforce limit is not exceeded. The process is deemed complete once thethird rotation transmitting assembly 260 reaches a hard stop or a forcethreshold as detected by the strain gauge assembly 320. This indicatesthat the knife has successfully dissected the tissue. Completion of thecutting sequence is indicated by another tone and the LED stops flashingand remains lit.

With reference to FIG. 82F, after the stapling and cutting sequences arecomplete, the user begins an unclamping sequence to release the anvilassembly 510 from the trocar member 274 by pressing on the top of thetoggle control button 30. As the toggle control button 30 is pressed up,the trocar member 274 is automatically extended distally, thereby movingthe anvil assembly 510 away from circular reload 400 and unclamping thetissue to the preset anvil tilt distance. The unclamping sequence isillustrated on the display screen 146. In particular, an unclampinganimation shows the anvil assembly 510 moving distally and the headassembly 512 being tilted. In addition, the display screen 146 alsoshows a lock icon to show that the anvil assembly 510 is secured to thetrocar member 274. Once the anvil assembly 510 is moved away fromcircular reload 400 to its tilt distance, the display screen 146 showsthe anvil assembly 510 in the extended state with the head assembly 512in the tilted state. This indicates that the user may remove thecircular adapter assembly 200 from the patient. The LED then turns off.Once circular adapter assembly 200 is removed, the user then may unlockthe anvil assembly 510 from the trocar member 274 by pressing one of theleft-side or right-side control buttons 32 a, 32 b, 34 a, 34 b of the ofthe power handle 101 for a predetermined period of time (e.g., 3 secondsor more). The display screen 146 shows which button needs to be pressedon the power handle 101 to unlock the anvil assembly 510. As the user ispressing one of the control buttons 32 a, 32 b, 34 a, 34 b, the displayscreen 146 displays a countdown (e.g., 3, 2, 1) and the lock icon isshown to be in the unlocked state. At this point, the anvil assembly 510is unlocked and may be removed. The user may then remove reload 400 aswell as the severed tissue from the resection procedure. Circularadapter assembly 200 is also detached from handle assembly 100 and iscleaned and sterilized for later reuse. The shell housing 10 is openedand discarded, with the power handle 101 being removed therefrom forreuse.

Regarding cleaning and/or sterilizing of the adapter assembly 200 forlater reuse, the inside of the adapter assembly 200 is sealed againstany fluid or moisture ingress, or most fluid or moisture ingress. In theevent that fluid or moisture should enter the inside of the adapterassembly 200, during the surgical procedure or during thecleaning/sterilizing process, a sterility of the adapter assembly 200(for subsequent use) and electronic functionality (e.g., of theelectrical assembly 310, see FIG. 53 ) may be affected. Any fluid ormoisture entering the adapter assembly 200 can be reliably evacuated ifan internal temperature of the adapter assembly 200 reaches a highenough temperature or a long enough period of time, during anysterilizing and/or autoclaving cycles. Accordingly, the adapter assembly200 is provided with certain features to better ensure that full fluidor moisture evacuation is achieved by the end of the autoclave cycle,irrespective of variations in the settings of the autoclave equipmentand/or an interior temperature of the adapter assembly 200 achievedduring the autoclave cycle.

In accordance with the present disclosure, in order to address theabove-noted occurrences of fluid or moisture ingress and egress from theadapter assembly 200, the adapter assembly 200 is provided with thermaldata logging features. Specifically, turning momentarily back to FIG. 53, electronic assembly 310 of the adapter assembly 200, and morespecifically, the circuit board 312 b of proximal pin connector 312thereof, may include an electronic temperature sensor 312 c (e.g., athermistor) that is incorporated on the circuit board 312 b. Theelectronic temperature sensor 312 c can be queried by an onboardmicroprocessor (not shown) of the circuit board 312 b to log atemperature of the adapter assembly 200.

By achieving a certain temperature threshold and/or a certainduration/time threshold, it has been established that a correlationexists with complete moisture evacuation/egress from the adapterassembly 200, during a sterilizing or autoclaving cycle or the like.According to the present disclosure, upon connecting the adapterassembly 200 to the power handle 101, the user can be provided withinformation regarding the complete sterilizing/autoclaving of theadapter assembly 200 and/or the complete evacuation of fluid or moisturefrom within the adapter assembly 200. For example, this may beaccomplished by providing a discrete indicator (not shown) on theadapter assembly 200 and/or by activating an image/signal on displayscreen 146 (see FIG. 12 ).

It is further contemplated that in addition to, or in lieu of theelectronic temperature sensor 312 c, the adapter assembly 200 mayinclude a mechanical temperature logger (not shown). For example, themechanical temperature logger may include a piece of wax having a knownsize, mass, melting point, etc., and which piece of wax would melt aftera minimum temperature threshold is obtained during thesterilization/autoclaving cycles, thereby indicating that appropriateheat has been applied for an appropriate period of time to indicate thatfluid or moisture has been fully evacuated.

In accordance with a method of the present disclosure, following asurgical procedure, being that the adapter assembly 200 is reusable, theadapter assembly 200 is subjected to a cleaning, sterilizing and/orautoclaving cycle where cleaning fluids are injected into the adapterassembly 200 (possible under pressure), where the cleaning fluids aredrained from the adapter assembly 200 (possible under a negativepressure), and where the adapter assembly 200 is heated for a set periodof time, and at a set temperature, to fully evacuate the cleaning fluidtherefrom. During the sterilizing/autoclaving cycle, the electronictemperature sensor 312 c of the adapter assembly 200 will monitor thetemperature and the time, and then log a maximum temperature and/or logthe duration of the sterilizing/autoclaving cycle. If an acceptablemaximum temperature is attained, and if the duration of thesterilizing/autoclaving cycle has taken place for a minimum amount oftime, then the electronic temperature sensor 312 c may record and logthe event as a successful sterilizing/autoclaving cycle; increment acounter thereof; update a log thereof to indicate that there are acertain number of remaining sterilizing/autoclaving cycle are available;log that no further sterilizing/autoclaving cycle are available; and/orlog that the sterilizing/autoclaving cycle was unsuccessful orinsufficient.

Thereafter, when the adapter assembly 200 is connected to the powerhandle 101, the main controller 147 of the power handle 101 interrogatesthe electronic temperature sensor 312 c to access the event log thereofand activate a signal or the display screen 146 which is commensuratewith the information contained in the event log of the electronictemperature sensor 312 c. For example, the power handle 101 can activatea signal indicating that the adapter assembly 200 has been properlysterilized and is ready for use, that the adapter assembly 200 has notbeen properly sterilized, or that a life-cycle of the adapter assembly200 is complete and may not be used further (e.g., disabling use of thepower handle 101 and/or the adapter assembly 200).

In accordance with the present disclosure, with reference once again toFIG. 82E, after the stapling and cutting sequences are complete, toprevent the tilted anvil assembly 510 (e.g., the anvil assembly 510 withthe head assembly 512 in the titled condition) from clamping against thecircular reload 400, and potentially pinching and/or trappinganastomosed tissue between the head assembly 512 and the circular reload400, the position of the trocar member 274 is monitored by the maincontroller 147 of the power handle 101. In this manner, when the powerhandle 101 is in this “surgical site extraction state” (that is, afterthe anastomosis is complete, and before the surgical device is removedfrom the surgical site), and when the trocar member 274 (of the trocarassembly 270 of the adapter assembly 200, see FIGS. 28 and 82E) is in aposition such that the head assembly 512 of the anvil assembly 510 isclose to the reload 400 (and may allow tissue to become trapped betweenthe tilted head assembly 512 (see FIG. 23 a ) of the anvil assembly 510and the reload 400), the force exerted on the strain gauge assembly 320(see FIGS. 52-54 ) is monitored (by main controller 147) to detectif/when the tilted head assembly 512 of the anvil assembly 510 isdrawn/re-drawn into the reload 400.

Accordingly, during the “surgical site extraction state” (e.g., thetilted head assembly 512 being drawn/re-drawn into the reload 400),if/when a predetermined threshold force, exerted on the strain gaugeassembly 320, is exceeded (e.g., by the tilted head assembly 512pinching or trapping tissue against a surface of the reload 400 or thelike), the main controller 147 may disable or stop the power handle 101from further moving the tilted head assembly 512 towards the reload 400,thereby stopping any undesired pinching or trapping of tissue betweenthe head assembly 512 and the reload 400. Further, it is contemplatedthat the main controller 147 may activate an audible, visual, and/ortactile alert for the user. As can be appreciated, entry of the maincontroller 147 into a “re-clamp” monitoring state may be contingent uponthe relative size and position of the trocar assembly 270, the centerrod assembly 514 and/or head assembly 512, as well and the relative size(e.g., staple size, knife diameter, etc.) of the reload 400 that isattached to the adapter assembly 200.

The powered stapler according to the present disclosure is alsoconfigured to enter recovery states during the clamping, stapling, andcutting sequences if any of the components, e.g., the power handle 101,circular adapter assembly 200, circular reload 400, and/or the anvilassembly 510, encounter errors. The recovery states are software statesexecuted by main controller 147 that guide the user through correctingand/or troubleshooting the errors and allow the user to resume any ofthe clamping, stapling, and cutting sequences once the error iscorrected.

At the start of each operational sequence (e.g., clamping, stapling,firing, etc.), the main controller 147 writes to the storage device 407of the circular adapter assembly 200 a recovery code associated with theoperational sequence. Thus, at the start of the procedure the storagedevice 407 stores an initialization recovery code indicating that thecircular adapter assembly 200 has not yet been used. However, as thecircular adapter assembly 200 is used throughout the procedure, namely,progressing through the different sequences described above,corresponding recovery codes are written to the storage device 407. Inaddition, the main controller 147 writes corresponding recovery statesto the memory 141. In either instance, this allows for replacement ofeither of the adapter assembly 200 and/or the power handle 101 dependingon the error state as both of the components store the last recoverystate locally, namely, in the storage device 407 or the memory 141,respectively.

With reference to FIG. 87A, which shows a recovery procedure during thestapling sequence and FIG. 88A, which shows a recovery procedure duringthe cutting sequence, during the procedure there may be instances thatthe power handle 101 identifies a flaw with one or more of thecomponents of the power handle 101, the circular adapter assembly 200,and/or the reload 400. These recovery procedures are illustrative andsimilar procedures are also envisioned to be implemented in otheroperational sequences of the power handle 101, e.g., clamping sequence.The recovery procedures may include, but are not limited to, attaching anew power handle 101 to an adapter assembly 200 that is inserted intothe patient, replacing the adapter assembly 200 and/or the reload 400.

When an adapter assembly 200 is attached to the power handle 101, thepower handle 101 reads the recovery code from the storage device 407 todetermine the state of the adapter assembly 200. The recovery code waswritten when the adapter assembly 200 was previously detached from thepower handle 101. As noted above, at the start of the procedure, therecovery code indicates the initial state, which directs the powerhandle 101 to transition into start-up sequence, e.g., calibration. Ifthe adapter assembly 200 was detached in the middle of the procedure,e.g., clamping, stapling, cutting, etc., the corresponding recovery codeprovides the entry point back into the mainline flow after performing arecovery procedure. This allows the operator to continue the surgicalprocedure at the point where the adapter assembly 200 was originallydetached.

Similarly, in situations where the power handle 101 is being replaced, anew power handle 101 is configured to read the recovery state from theadapter assembly 200. This allows the new power handle 101 to resumeoperation of the previous power handle 101. Thus, during any of theoperational sequences, e.g., clamping, stapling, and cutting, theadapter assembly 200 may be left in the corresponding configuration,e.g., clamped, stapled, etc., and after the new power handle 101 isattached, operation may be resumed.

It will be understood that various modifications may be made to theembodiments of the presently disclosed adapter assemblies. Therefore,the above description should not be construed as limiting, but merely asexemplifications of embodiments. Those skilled in the art will envisionother modifications within the scope and spirit of the presentdisclosure.

What is claimed is:
 1. A handheld electromechanical surgical devicecapable of effectuating a surgical procedure, the surgical devicecomprising: a handle assembly including: a power source; at least onemotor coupled to the power source; and a controller configured tocontrol the motor; an adapter assembly coupled to and extending from thehandle assembly, the adapter assembly including: a force transmittingand rotation converting assembly for receiving and communicating arotation from the at least one motor of the handle assembly to axiallytranslating forces of a driven assembly thereof; and an electricalassembly having a proximal end in communication with the controller ofthe handle assembly, and a distal end; and a reload configured toselectively connect to a distal portion of the adapter assembly, thereload including: a reload housing; an annular array of staples disposedwithin the reload housing; an annular staple pusher disposed within thereload housing and being configured for ejecting the staples; and a chipassembly supported within the reload housing, the chip assemblyincluding: a chip housing defining a cavity having an open end orientedin a proximal direction; a pair of contact members retained within thecavity of the chip housing at a location recessed within the cavity; anda data storage device retained in the cavity of the chip housing andbeing located between the pair of contact members, the data storagedevice being selectively connectable to the distal end of the electricalassembly of the adapter assembly, wherein the data storage devicereceives and stores performance data of the surgical device from thecontroller of the handle assembly.
 2. The surgical device according toclaim 1, wherein the data storage device of the reload includesinformation pre-stored thereon prior to any use thereof, the pre-storedinformation includes at least one of lot number, staple size, knifediameter, lumen size, fire count, manufacturing stroke offsets,excessive force index, shipping cap assembly presence, or demonstrationmodes.
 3. The surgical device according to claim 1, wherein the datastorage device of the reload is configured to have performance datawritten thereto and stored thereon during or following any use thereof.4. The surgical device according to claim 3, wherein the data storagedevice of the reload is configured to have performance data writtenthereto and stored thereon following a successful or unsuccessful firingof the surgical device.
 5. The surgical device according to claim 4,wherein the performance data written and stored to the data storagedevice of the reload includes clamping forces for the surgicalprocedure, stapling forces for the surgical procedure, cutting forcesfor the surgical procedure, a maximum clamping force, a maximum staplingforce or a maximum cutting force.
 6. The surgical device according toclaim 5, wherein the performance data is written and stored to thecontroller of the handle assembly.
 7. The surgical device according toclaim 1, wherein, during or following any use of the surgical device,performance data related to the use of the surgical device is written toand stored in the data storage device of the reload.
 8. The surgicaldevice according to claim 7, wherein, following a successful orunsuccessful firing of the surgical device, performance data related tothe successful or unsuccessful firing is written to and stored in thedata storage device of the reload.
 9. The surgical device according toclaim 8, wherein the performance data written and stored to the datastorage device of the reload includes clamping forces for the surgicalprocedure, stapling forces for the surgical procedure, cutting forcesfor the surgical procedure, a maximum clamping force, a maximum staplingforce or a maximum cutting force.
 10. The surgical device according toclaim 9, wherein the data storage device of the reload includesinformation pre-stored thereon prior to any use thereof, the pre-storedinformation includes at least one of lot number, staple size, knifediameter, lumen size, fire count, manufacturing stroke offsets,excessive force index, shipping cap assembly presence, or demonstrationmodes.
 11. The surgical device according to claim 10, wherein theperformance data is written and stored to the controller of the handleassembly.
 12. A surgical staple reload for use with a handheldelectromechanical surgical device during a surgical procedure, thesurgical staple reload comprising: a reload housing configured toselectively connect to a distal portion of the handheldelectromechanical surgical device; an annular array of staples disposedwithin the reload housing; an annular staple pusher disposed within thereload housing and being configured for ejecting the staples; and a chipassembly supported within the reload housing, the chip assemblyincluding: a chip housing defining a cavity having an open end orientedin a proximal direction; a pair of contact members retained within thecavity of the chip housing; and a data storage device retained in thecavity of the chip housing and being located between the pair of contactmembers, the data storage device being selectively connectable to anelectrical assembly of the handheld electromechanical surgical device,wherein the data storage device receives and stores performance data ofthe handheld electromechanical surgical device from a controller of thehandheld electromechanical surgical device.
 13. The surgical staplereload according to claim 12, wherein the data storage device includesinformation pre-stored thereon prior to any use thereof, the pre-storedinformation includes at least one of lot number, staple size, knifediameter, lumen size, fire count, manufacturing stroke offsets,excessive force index, shipping cap assembly presence, or demonstrationmodes.
 14. The surgical staple reload according to claim 12, wherein thedata storage device is configured to have performance data writtenthereto and stored thereon during or following any use thereof.
 15. Thesurgical staple reload according to claim 14, wherein the data storagedevice is configured to have performance data written thereto and storedthereon following a successful or unsuccessful firing of the handheldelectromechanical surgical device.
 16. The surgical staple reloadaccording to claim 15, wherein the performance data written and storedto the data storage device includes clamping forces for the surgicalprocedure, stapling forces for the surgical procedure, cutting forcesfor the surgical procedure, a maximum clamping force, a maximum staplingforce or a maximum cutting force.
 17. The surgical staple reloadaccording to claim 16, wherein the performance data is written andstored to the controller of the handheld electromechanical surgicaldevice.
 18. The surgical staple reload according to claim 12, wherein,during or following any use of the handheld electromechanical surgicaldevice, performance data related to the use of the handheldelectromechanical surgical device is written to and stored in the datastorage device of the staple reload.
 19. The surgical staple reloadaccording to claim 18, wherein, following a successful or unsuccessfulfiring of the handheld electromechanical surgical device, performancedata related to the successful or unsuccessful firing is written to andstored in the data storage device of the reload.
 20. The surgical staplereload according to claim 19, wherein the performance data written andstored to the data storage device includes clamping forces for thesurgical procedure, stapling forces for the surgical procedure, cuttingforces for the surgical procedure, a maximum clamping force, a maximumstapling force or a maximum cutting force.
 21. The surgical staplereload according to claim 20, wherein the data storage device includesinformation pre-stored thereon prior to any use thereof, the pre-storedinformation includes at least one of lot number, staple size, knifediameter, lumen size, fire count, manufacturing stroke offsets,excessive force index, shipping cap assembly presence, or demonstrationmodes.
 22. The surgical staple reload according to claim 21, wherein theperformance data is written and stored to the controller of the handheldelectromechanical surgical device.